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The product under investigation relates to a pharmaceutical composition containing a pyrimidine nitrogen base, thymine, and the essential amino acid tryptophan. This product seems to have effect on quality of life and enhance adverse affects of chemotherapy in cancer patients.
The primary objective of this study is to evaluate the impact of TK3 on the quality of life of patients receiving anti-neoplastic chemotherapy. The secondary objectives are to evaluate the influence of TK3 on the side effects caused by anti-neoplastic chemotherapy, tolerance to this treatment and the safety of the use of the TK3 product in cancer patients, accompanying the appearance of non-characteristic effects of the existing cancer type .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TK3 | Experimental | This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day |
|
| Placebo | Placebo Comparator | Placebo orally, to be taken three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TK3 | Drug | Tryptophan and thiamine as on oral supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy | use of quality of life questionaire QLQ-C30 | It depends on the chemotherapy schedule: 14 or 21 days |
| The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy | use of quality of life questionaire FACIT-F | It depends on the chemotherapy schedule: 14 or 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of TK3 on tolerance to anti-neoplastic chemotherapy, with emphasis on the most prevalent side effects, especially fatigue related to cancer treatment according to CTCAE scale of adverse events v 4.0 | use of CTCAE scale of adverse events v 4.0 and Edmonton scale | It depends on the chemotherapy schedule: 14 or 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de medicina do ABC-CEPHO | Santo André | São Paulo | 09060-870 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8433390 | Background | Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. | |
| 23272990 |
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Randomized, placebo-controlled
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| Drugs safety according to CTCAE scale of adverse events v 4.0 |
safety and tolerability |
| It depends on the chemotherapy schedule: 14 or 21 days |
| Butt Z, Lai JS, Rao D, Heinemann AW, Bill A, Cella D. Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale. J Psychosom Res. 2013 Jan;74(1):64-8. doi: 10.1016/j.jpsychores.2012.10.011. Epub 2012 Nov 15. |
| 20832987 | Background | Watanabe SM, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F. A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage. 2011 Feb;41(2):456-68. doi: 10.1016/j.jpainsymman.2010.04.020. Epub 2010 Sep 15. |
| 1714502 | Background | Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9. |
| 24015476 | Background | Monteiro Dda R, Almeida Mde A, Kruse MH. [Translation and cross-cultural adaptation of the Edmonton Symptom Assessment System for use in Palliative Care]. Rev Gaucha Enferm. 2013 Jun;34(2):163-71. doi: 10.1590/s1983-14472013000200021. Portuguese. |
| 21098316 | Background | Cocks K, King MT, Velikova G, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. J Clin Oncol. 2011 Jan 1;29(1):89-96. doi: 10.1200/JCO.2010.28.0107. Epub 2010 Nov 22. |
| 12118024 | Background | Osoba D, Slamon DJ, Burchmore M, Murphy M. Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer. J Clin Oncol. 2002 Jul 15;20(14):3106-13. doi: 10.1200/JCO.2002.03.090. |
| 26567010 | Background | Cortes J, Hudgens S, Twelves C, Perez EA, Awada A, Yelle L, McCutcheon S, Kaufman PA, Forsythe A, Velikova G. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulin mesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat. 2015 Dec;154(3):509-20. doi: 10.1007/s10549-015-3633-7. Epub 2015 Nov 14. |
| 19568958 | Background | Curran D, Pozzo C, Zaluski J, Dank M, Barone C, Valvere V, Yalcin S, Peschel C, Wenczl M, Goker E, Bugat R. Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial. Qual Life Res. 2009 Sep;18(7):853-61. doi: 10.1007/s11136-009-9493-z. Epub 2009 Jul 1. |
| 16157935 | Background | Brown J, Thorpe H, Napp V, Fairlamb DJ, Gower NH, Milroy R, Parmar MK, Rudd RM, Spiro SG, Stephens RJ, Waller D, West P, Peake MD. Assessment of quality of life in the supportive care setting of the big lung trial in non-small-cell lung cancer. J Clin Oncol. 2005 Oct 20;23(30):7417-27. doi: 10.1200/JCO.2005.09.158. Epub 2005 Sep 12. |
| 16782921 | Background | Southwest Oncology Group; Berry DL, Moinpour CM, Jiang CS, Ankerst DP, Petrylak DP, Vinson LV, Lara PN, Jones S, Taplin ME, Burch PA, Hussain MH, Crawford ED. Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. J Clin Oncol. 2006 Jun 20;24(18):2828-35. doi: 10.1200/JCO.2005.04.8207. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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