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One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight loss and malnutrition, which leads to a prognostic impact in a lower patient response to chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects, impacting treatment discontinuation and therefore, morbidity and survival of patients. The objective of this study is to describe the threshold of perception and recognition of basic tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy and after the second cycle, and analyze the effect in the developement of dysgeusia, as well as the association between these and the nutritional status and quality of life.
Lung cancer is the leading cause of death from malignancies in our country. It was recently reported to induce 11.5% of cancer deaths in Mexico, with a rate of 6.5 per 100 000 people.
Non-Small Cell Lung Cancer (NSCLC) accounts for 80% of all lung cancer cases. Less than 20% has resectable disease and in the National Cancer Institute of Mexico exclusively less than 2%, representing chemotherapy the standard of care in these patients.
One of the most widely used drug combinations is paclitaxel-cisplatin. It has been reported a prevalence of malnutrition in 60 to 79% in this type of cancer, being the major contributor to morbidity and mortality. The etiology resides both in the systemic effects of the tumor and toxic effects of treatment as low levels hematologic, nausea, vomiting, mucositis, anorexia, dysgeusia, among others.
Weight loss has a strong impact on the response to chemotherapy, radiotherapy and surgery, as well as increased toxic effects impacting the discontinuation of treatment and is considered an independent predictor of survival for most patients with NSCLC. Is estimated that over 20% of cancer patients the cause of death are inanition effects.
Among the most frequent symptoms in advanced unresectable cancer or its treatment that may affect food intake and hence nutritional status, are the early satiety and dysgeusia (61% and 46% respectively). As are difficult to change early satiety, dysgeusia is a field for selecting strategies in its management.
The dysgeusia is defined as a change in taste that can manifest as a distortion of taste, lack of taste (ageusia), decreased sensitivity of perception (hypogeusia) or increased sensitivity to some or all flavors (hypergeusia).
The development of dysgeusia have clinical significance in the etiology of cancer anorexia because it can affect eating habits and contribute to weight loss or malnutrition and consequently affect the quality of life.
The chemotherapy may contribute to dysgeusia. It has reported a prevalence of 56.3% of Dysgeusia in cancer patients under this type of treatment. As well, zinc deficiency has been associated with the hypogeusia, this metal to be involved at various levels in the physiology of the role of taste at various levels of cell several organization.
Several studies have linked consumption dysgeusia with energy and macronutrients, weight loss, lack of appetite and early satiety.
The type of tumor, stage, chemotherapy regimen and serum zinc levels are associated with dysgeusia, but the exact mechanism underlining these disturbances are not known at totality. No known if chemotherapy or before this is presented dysgeusia. In addition there are few studies in this area and with methodological weaknesses, among which include heterogeneous population (patients with a diagnosis of malignancy of breast, lung, prostate, multiple myeloma and lymphoma), different patterns of treatment(different chemotherapy drugs, radiotherapy schedules and combination of both forms of measurement of dysgeusia, besides the absence of dysgeusia baseline evaluation before chemotherapy to establish a causal association between chemotherapy and taste alteration.
Also, is unknown if dysgeusia impact on body composition determined by bioelectrical impedance, phase angle in and consumption of micronutrients (iron, sodium, zinc, B6, B12).
That's why is necessary to continue studying this phenomenon to develop a better understanding of the nature, frequency, severity and duration of dysgeusia in patients with advanced lung cancer, the role that zinc exerts in its development and its impact on consumption food, anthropometric parameters and quality of life in such patients before and after chemotherapy in the same regimen of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BASELINE | Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Dysgeusia (UMAMI Perception) | Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Change from Baseline in threshold of perception at 6 weeks |
| Dysgeusia (UMAMI Recognition) | Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Change from Baseline in threshold of perception at 6 weeks |
| Dysgeusia (SWEET Perception) | Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Change from Baseline in threshold of perception at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BODY COMPOSITION | fat mass and lean body mass pre-post chemotherapy | Change from Baseline in perception and recognition thresholds at 6 weeks |
| Body Mass Index | Body mass index, using the formula kg/m^2 |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Oscar G Arrieta, MD M Sc | Mexico. Nacional Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute of Mexico | Mexico City | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17659812 | Background | Ruiz-Godoy L, Rizo Rios P, Sanchez Cervantes F, Osornio-Vargas A, Garcia-Cuellar C, Meneses Garcia A. Mortality due to lung cancer in Mexico. Lung Cancer. 2007 Nov;58(2):184-90. doi: 10.1016/j.lungcan.2007.06.007. Epub 2007 Jul 30. | |
| 14649565 | Background | Sarhill N, Mahmoud FA, Christie R, Tahir A. Assessment of nutritional status and fluid deficits in advanced cancer. Am J Hosp Palliat Care. 2003 Nov-Dec;20(6):465-73. doi: 10.1177/104990910302000610. |
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We invited to participate 40 patients who completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.
We recruit patients since September 2010 to July 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-chemotherapy Patientes =40 | Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We invited to participate 72 patients with NSCLC newly diagnosed, but only 40 patients completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-chemotherapy Patientes =40 | Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dysgeusia (UMAMI Perception) | Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Posted | Median | Full Range | μmol/ml | Change from Baseline in threshold of perception at 6 weeks |
|
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Serious and/or Other [non-serious] adverse events were not collected/assessed for this observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LUNG CANCER PATIENTS | any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational |
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No analysis of serum zinc was performed and a small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oscar Arrieta | Instituto Nacional de Cancerología de México | 5628-0400 | 832 | ogarrieta@gmail.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004408 | Dysgeusia |
| D013651 | Taste Disorders |
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| Dysgeusia (SWEET Recognition) | Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Change from Baseline in threshold of perception at 6 weeks |
| Dysgeusia (BITTER Perception) | Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Change from Baseline in threshold of perception at 6 weeks |
| Dysgeusia (BITTER Recognition) | Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Change from Baseline in threshold of perception at 6 weeks |
| Dysgeusia (UMAMI Dilutions Dichotomized) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception) | pre - post chemotherapy (6 weeks) |
| Dysgeusia (SWEET Dilutions Dichotomized) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste. | pre - post chemotherapy (6 weeks) |
| Dysgeusia (BITTER Dilutions Dichotomized) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes | pre - post chemotherapy (6 weeks) |
| Change from Baseline in threshold of perception and recognition at 6 weeks |
| Subjective Global Assessment | validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A). | descriptive values before chemotherapy |
| PROTEIN AND FAT Consumption | energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
| IRON Consumption | IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
| Quality o f Life | The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating. | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
| Change From Baseline in Albumin After 2 Cycles of Chemotherapy | comparison of patients who increased or decreased their sensibility to the PT of umami taste | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
| Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) | comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating. | participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks |
| Global Status of Quality of Life (C-30,LC13 EORTC) | differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste. score of scale 0-100, a higher score represents better overall state. | time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks |
| 19665873 | Background | Wie GA, Cho YA, Kim SY, Kim SM, Bae JM, Joung H. Prevalence and risk factors of malnutrition among cancer patients according to tumor location and stage in the National Cancer Center in Korea. Nutrition. 2010 Mar;26(3):263-8. doi: 10.1016/j.nut.2009.04.013. Epub 2009 Aug 8. |
| 20170547 | Background | Arrieta O, Michel Ortega RM, Villanueva-Rodriguez G, Serna-Thome MG, Flores-Estrada D, Diaz-Romero C, Rodriguez CM, Martinez L, Sanchez-Lara K. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study. BMC Cancer. 2010 Feb 21;10:50. doi: 10.1186/1471-2407-10-50. |
| 19408460 | Background | Halyard MY. Taste and smell alterations in cancer patients--real problems with few solutions. J Support Oncol. 2009 Mar-Apr;7(2):68-9. No abstract available. |
| 19408458 | Background | Hong JH, Omur-Ozbek P, Stanek BT, Dietrich AM, Duncan SE, Lee YW, Lesser G. Taste and odor abnormalities in cancer patients. J Support Oncol. 2009 Mar-Apr;7(2):58-65. |
| 10736361 | Background | Rolls ET. The representation of umami taste in the taste cortex. J Nutr. 2000 Apr;130(4S Suppl):960S-5S. doi: 10.1093/jn/130.4.960S. |
| 11762967 | Background | Comeau TB, Epstein JB, Migas C. Taste and smell dysfunction in patients receiving chemotherapy: a review of current knowledge. Support Care Cancer. 2001 Nov;9(8):575-80. doi: 10.1007/s005200100279. |
| 21865574 | Background | Arrieta O, Hernandez-Pedro N, Fernandez-Gonzalez-Aragon MC, Saavedra-Perez D, Campos-Parra AD, Rios-Trejo MA, Ceron-Lizarraga T, Martinez-Barrera L, Pineda B, Ordonez G, Ortiz-Plata A, Granados-Soto V, Sotelo J. Retinoic acid reduces chemotherapy-induced neuropathy in an animal model and patients with lung cancer. Neurology. 2011 Sep 6;77(10):987-95. doi: 10.1212/WNL.0b013e31822e045c. Epub 2011 Aug 24. |
| 17710445 | Background | Bernhardson BM, Tishelman C, Rutqvist LE. Self-reported taste and smell changes during cancer chemotherapy. Support Care Cancer. 2008 Mar;16(3):275-83. doi: 10.1007/s00520-007-0319-7. Epub 2007 Aug 21. |
| 19175932 | Background | Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37. |
| 9617194 | Background | Hernandez-Avila M, Romieu I, Parra S, Hernandez-Avila J, Madrigal H, Willett W. Validity and reproducibility of a food frequency questionnaire to assess dietary intake of women living in Mexico City. Salud Publica Mex. 1998 Mar-Apr;40(2):133-40. doi: 10.1590/s0036-36341998000200005. |
| 11963449 | Background | Thoresen L, Fjeldstad I, Krogstad K, Kaasa S, Falkmer UG. Nutritional status of patients with advanced cancer: the value of using the subjective global assessment of nutritional status as a screening tool. Palliat Med. 2002 Jan;16(1):33-42. doi: 10.1191/0269216302pm486oa. |
| 12122555 | Background | Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412. |
| 20060626 | Background | Muscaritoli M, Anker SD, Argiles J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8. |
| 17394940 | Background | Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046. |
| 20306090 | Result | Brennan MT, Elting LS, Spijkervet FK. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO: methodology and quality of the literature. Support Care Cancer. 2010 Aug;18(8):979-84. doi: 10.1007/s00520-010-0856-3. Epub 2010 Mar 20. |
| 6413712 | Result | Gallagher P, Tweedle DE. Taste threshold and acceptability of commercial diets in cancer patients. JPEN J Parenter Enteral Nutr. 1983 Jul-Aug;7(4):361-3. doi: 10.1177/0148607183007004361. |
| 2305710 | Result | Mattes RD, Cowart BJ, Schiavo MA, Arnold C, Garrison B, Kare MR, Lowry LD. Dietary evaluation of patients with smell and/or taste disorders. Am J Clin Nutr. 1990 Feb;51(2):233-40. doi: 10.1093/ajcn/51.2.233. |
| 17280921 | Result | Hutton JL, Baracos VE, Wismer WV. Chemosensory dysfunction is a primary factor in the evolution of declining nutritional status and quality of life in patients with advanced cancer. J Pain Symptom Manage. 2007 Feb;33(2):156-65. doi: 10.1016/j.jpainsymman.2006.07.017. |
| 19273394 | Result | Rehwaldt M, Wickham R, Purl S, Tariman J, Blendowski C, Shott S, Lappe M. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum. 2009 Mar;36(2):E47-56. doi: 10.1188/09.onf.e47-e56. |
| 19289621 | Result | Steinbach S, Hummel T, Bohner C, Berktold S, Hundt W, Kriner M, Heinrich P, Sommer H, Hanusch C, Prechtl A, Schmidt B, Bauerfeind I, Seck K, Jacobs VR, Schmalfeldt B, Harbeck N. Qualitative and quantitative assessment of taste and smell changes in patients undergoing chemotherapy for breast cancer or gynecologic malignancies. J Clin Oncol. 2009 Apr 10;27(11):1899-905. doi: 10.1200/JCO.2008.19.2690. Epub 2009 Mar 16. |
| 20667968 | Result | Zabernigg A, Gamper EM, Giesinger JM, Rumpold G, Kemmler G, Gattringer K, Sperner-Unterweger B, Holzner B. Taste alterations in cancer patients receiving chemotherapy: a neglected side effect? Oncologist. 2010;15(8):913-20. doi: 10.1634/theoncologist.2009-0333. Epub 2010 Jul 28. |
| 20334666 | Result | Sanchez-Lara K, Sosa-Sanchez R, Green-Renner D, Rodriguez C, Laviano A, Motola-Kuba D, Arrieta O. Influence of taste disorders on dietary behaviors in cancer patients under chemotherapy. Nutr J. 2010 Mar 24;9:15. doi: 10.1186/1475-2891-9-15. |
| 21351269 | Result | Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. |
| 26943275 | Derived | Turcott JG, Juarez-Hernandez E, De la Torre-Vallejo M, Sanchez-Lara K, Luvian-Morales J, Arrieta O. Value: Changes in the Detection and Recognition Thresholds of Three Basic Tastes in Lung Cancer Patients Receiving Cisplatin and Paclitaxel and Its Association with Nutritional and Quality of Life Parameters. Nutr Cancer. 2016;68(2):241-9. doi: 10.1080/01635581.2016.1144075. Epub 2016 Mar 4. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Post-chemotherapy Patients |
measurement post-chemotherapy |
|
|
|
| Secondary | BODY COMPOSITION | fat mass and lean body mass pre-post chemotherapy | Posted | Mean | Standard Deviation | kg | Change from Baseline in perception and recognition thresholds at 6 weeks |
|
|
|
|
| Secondary | Body Mass Index | Body mass index, using the formula kg/m^2 | Posted | Mean | Standard Deviation | kg/m^2 | Change from Baseline in threshold of perception and recognition at 6 weeks |
|
|
|
|
| Secondary | Subjective Global Assessment | validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A). | Posted | Number | participants | descriptive values before chemotherapy |
|
|
|
|
| Secondary | PROTEIN AND FAT Consumption | energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy | Posted | Mean | Standard Deviation | gr | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
|
|
|
|
| Secondary | IRON Consumption | IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy | Posted | Mean | Standard Deviation | mg | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
|
|
|
| Primary | Dysgeusia (UMAMI Recognition) | Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later. | Posted | Median | Full Range | μmol/ml | Change from Baseline in threshold of perception at 6 weeks |
|
|
|
|
| Secondary | Quality o f Life | The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating. | Posted | Median | Full Range | Scores on a scale | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in Albumin After 2 Cycles of Chemotherapy | comparison of patients who increased or decreased their sensibility to the PT of umami taste | Posted | Mean | Standard Deviation | g/dL | participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks |
|
|
|
|
| Secondary | Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) | comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating. | Posted | Median | Full Range | Units on a scale | participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks |
|
|
|
|
| Secondary | Global Status of Quality of Life (C-30,LC13 EORTC) | differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste. score of scale 0-100, a higher score represents better overall state. | Posted | Median | Inter-Quartile Range | units on a scale | time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks |
|
|
|
|
| Primary | Dysgeusia (SWEET Perception) | Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later. | Posted | Median | Full Range | μmol/ml | Change from Baseline in threshold of perception at 6 weeks |
|
|
|
|
| Primary | Dysgeusia (SWEET Recognition) | Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Posted | Median | Full Range | μmol/ml | Change from Baseline in threshold of perception at 6 weeks |
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| Primary | Dysgeusia (BITTER Perception) | Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Posted | Mean | Full Range | μmol/ml | Change from Baseline in threshold of perception at 6 weeks |
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| Primary | Dysgeusia (BITTER Recognition) | Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste. | Posted | Median | Full Range | μmol/ml | Change from Baseline in threshold of perception at 6 weeks |
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| Primary | Dysgeusia (UMAMI Dilutions Dichotomized) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception) | Posted | Number | participants | pre - post chemotherapy (6 weeks) |
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| Primary | Dysgeusia (SWEET Dilutions Dichotomized) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste. | we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy | Posted | Number | participants | pre - post chemotherapy (6 weeks) |
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| Primary | Dysgeusia (BITTER Dilutions Dichotomized) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes | Posted | Number | participants | pre - post chemotherapy (6 weeks) |
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| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| t-test, 2 sided |
| 0.694 |
| 2-Sided |
| Superiority or Other (legacy) |
| fat |
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| t-test, 2 sided |
| 0.010 |
| 2-Sided |
| Superiority or Other (legacy) |
| FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy | t-test, 2 sided | 0.004 | 2-Sided | Superiority or Other (legacy) |
| Emotional functioning |
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| Fatigue |
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| Appetite loss |
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| Constipation |
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| Wilcoxon (Mann-Whitney) |
| 0.293 |
clinically significant |
| 2-Sided |
| Superiority or Other (legacy) |
| change in emotional functioning of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire | Wilcoxon (Mann-Whitney) | 0.009 | 2-Sided | Superiority or Other (legacy) |
| change in fatigue scale of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire | Wilcoxon (Mann-Whitney) | 0.213 | clinically significant | 2-Sided | Superiority or Other (legacy) |
| change in appetite loss of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire | Wilcoxon (Mann-Whitney) | 0.595 | clinically significant | 2-Sided | Superiority or Other (legacy) |
| change in constipation scale of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire | Wilcoxon (Mann-Whitney) | 0.068 | clinically significant | 2-Sided | Superiority or Other (legacy) |