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The goal of this observational study is to examine how frequently changes in taste occur in people with early-stage breast cancer who receive chemotherapy. It will also look at how these taste changes affect nutrition and quality of life. The main questions this study aims to answer are:
Participants are women with non-metastatic breast cancer who are receiving chemotherapy before or after surgery.
Researchers will use standardized taste tests to measure how well participants can perceive different flavors. These tests are designed to provide accurate and reproducible results.
Participants will:
Dysgeusia, defined as an altered perception of taste, is a frequent but understudied adverse effect of several chemotherapy regimens used for the treatment of breast cancer. Taste alterations may arise from direct cytotoxic effects on taste receptor cells, changes in saliva composition, mucosal inflammation, altered signal transduction, or central nervous system effects. These disturbances can lead to reduced food enjoyment, alterations in dietary patterns, and potential deterioration of nutritional and functional status.
Although dysgeusia is commonly reported in clinical practice, estimates of its prevalence vary widely due to heterogeneous methodologies and the predominant reliance on self-reported symptoms rather than standardized sensory testing. Studies that objectively quantify changes in taste recognition thresholds during chemotherapy are limited, and little is known about specific aspects such as umami perception or chemesthetic sensitivity. Furthermore, factors that may predispose individual patients to developing dysgeusia-such as baseline taster status, nutritional condition, or specific treatment characteristics-remain poorly characterized.
This observational pilot study was designed to provide objective, reproducible data on taste function in patients with non-metastatic breast cancer receiving standard neoadjuvant or adjuvant chemotherapy. A combination of validated sensory tools, including taste strips and chemesthetic tests, is used to measure changes in taste perception over the course of treatment. Standardized methods were selected to ensure high sensitivity and repeatability and to allow quantitative comparison across different time points.
The study also integrates nutritional assessment and quality-of-life evaluation to explore the broader clinical implications of dysgeusia. Particular attention is given to potential associations between objective taste alterations, patient-reported symptoms, and parameters such as nutritional status, dietary intake, and functional well-being. Given the scarcity of comprehensive, methodologically rigorous studies in this area, the data generated may help clarify the clinical burden of dysgeusia and inform strategies to mitigate its impact on patients undergoing chemotherapy for breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Metastatic Breast Cancer Patients Receiving Chemotherapy | This group includes male and female participants diagnosed with non-metastatic breast cancer who are receiving neoadjuvant or adjuvant chemotherapy according to standard clinical practice. All participants are treated at the Oncology Unit of Michele and Pietro Ferrero Hospital in Verduno. Eligible participants are those for whom chemotherapy is indicated as part of routine care and who are willing and able to complete sensory tests, nutritional assessments, and quality-of-life questionnaires during the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taste Assessment / Nutritional Assessment / Quality of Life Assessment | Other | Participants will undergo additional procedures as part of the study to assess taste function, nutritional status, and quality of life. These procedures include:
All procedures are non-invasive and performed in addition to the participants' standard chemotherapy treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dysgeusia during chemotherapy | The primary endpoint is the incidence of dysgeusia after the start of chemotherapy in participants with non-metastatic breast cancer. Taste perception will be evaluated using standardized taste strips to determine recognition thresholds for four basic tastes (sweet, sour, salty, and bitter). Dysgeusia will be considered present if the total taste strip score is lower than 9 at any of the evaluated time points. | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after the completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative changes in taste recognition thresholds | Quantitative evaluation of recognition thresholds for the five basic tastes (sweet, sour, salty, bitter, and umami) to assess changes in taste perception during and after chemotherapy. | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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This group includes male and female participants diagnosed with non-metastatic breast cancer who are receiving neoadjuvant or adjuvant chemotherapy according to standard clinical practice. Participants are treated at the Oncology Unit of Michele and Pietro Ferrero Hospital in Verduno. Eligible participants are those for whom chemotherapy is indicated as part of their routine care, and who are willing and able to complete sensory tests, nutritional assessments, and quality of life questionnaires during the study period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cloè Dalla Costa, MD | Contact | +39.0172.1408493 | cdallacosta@aslcn2.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368973 | Background | Sawicki CM, Janal MN, Nicholson SJ, Wu AK, Schmidt BL, Albertson DG. Oral cancer patients experience mechanical and chemical sensitivity at the site of the cancer. BMC Cancer. 2022 Nov 11;22(1):1165. doi: 10.1186/s12885-022-10282-3. | |
| 26943275 | Background | 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. |
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| Chemesthetic sensitivity assessed by capsaicin strips | Evaluation of chemesthetic function using strips impregnated with capsaicin at four increasing concentrations to assess oral sensitivity to chemical stimuli. | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| Taster status assessment | Assessment of participants' "taster status" (ability to detect bitter compounds) to evaluate its potential correlation with the subsequent development of dysgeusia. | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| Chemotherapy-induced taste alteration (CiTAS) questionnaire | Evaluation of participant-reported taste alterations using the Chemotherapy-Induced Taste Alteration Scale (CiTAS) and comparison with objective sensory test findings. Score range: 1 to 5. Higher scores indicate more severe taste alterations. | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| Nutritional status assessment | Evaluation of nutritional status using the Global Leadership Initiative on Malnutrition (GLIM) criteria and measurement of phase angle using bioelectrical impedance analysis (BIA). | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| Caloric and macronutrient intake | Assessment of caloric and macronutrient intake using 24-hour dietary recall interviews to determine changes during and after chemotherapy. | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| Quality of life assessment (FACT-G) | Evaluation of quality of life using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The total score is derived by summing scores from four domains (physical, social/family, emotional, and functional well-being). Each item is scored on a 5-point scale from 0 ("Not at all") to 4 ("Very much"). | - Baseline: within 15 days before the start of chemotherapy - Mid-treatment: approximately 3 months after baseline - End of chemotherapy: within 15 days after completion of chemotherapy - Follow-up: 2 months after the end of chemotherapy |
| 30927113 | Background | Epstein JB, de Andrade E Silva SM, Epstein GL, Leal JHS, Barasch A, Smutzer G. Taste disorders following cancer treatment: report of a case series. Support Care Cancer. 2019 Dec;27(12):4587-4595. doi: 10.1007/s00520-019-04758-5. Epub 2019 Mar 29. |
| 31554217 | Background | Nolden AA, Hwang LD, Boltong A, Reed DR. Chemosensory Changes from Cancer Treatment and Their Effects on Patients' Food Behavior: A Scoping Review. Nutrients. 2019 Sep 24;11(10):2285. doi: 10.3390/nu11102285. |
| 19221845 | Background | Landis BN, Welge-Luessen A, Bramerson A, Bende M, Mueller CA, Nordin S, Hummel T. "Taste Strips" - a rapid, lateralized, gustatory bedside identification test based on impregnated filter papers. J Neurol. 2009 Feb;256(2):242-8. doi: 10.1007/s00415-009-0088-y. Epub 2009 Feb 7. |
| 21774441 | Background | Mueller CA, Pintscher K, Renner B. Clinical test of gustatory function including umami taste. Ann Otol Rhinol Laryngol. 2011 Jun;120(6):358-62. doi: 10.1177/000348941112000602. |
| 12677732 | Background | Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6. |
| 36768861 | Background | Buttiron Webber T, Briata IM, DeCensi A, Cevasco I, Paleari L. Taste and Smell Disorders in Cancer Treatment: Results from an Integrative Rapid Systematic Review. Int J Mol Sci. 2023 Jan 28;24(3):2538. doi: 10.3390/ijms24032538. |
| ID | Term |
|---|---|
| D013651 | Taste Disorders |
| D001943 | Breast Neoplasms |
| D004408 | Dysgeusia |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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