The Effect of an Oral Supplement,TK3 (Tryptophan and Thiamine) on the Quality of Life and Chemotherapy Tolerance in Cancer Patients With Advanced Disease.

Cancer Clinical Trial

— TK3bFIIABC  

Official title:

Randomized, Placebo Controlled, Phase II Trial, on the Effect of an Oral Supplement,TK3 (Tryptophan and Thiamine) on the Quality of Life and Chemotherapy Tolerance in Cancer Patients With Advanced Disease.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03341286
• Other study ID #: TK3b FII ABC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 22, 2017
• Last updated: November 10, 2017
• Start date: November 2017
• Est. completion date: May 2019

Study information

• Verified date: October 2017
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who agree to study procedures and sign the informed consent

• Patients 18 years of age or older;

• Patients undergoing oncologic treatment for advanced neoplasms. It is understood by advanced patient disease patients with unresectable or with distant metastases.

• Participants should present at least one (1) of the following clinical side effects that can be assessed according to CTCAE (Version 4.0): fatigue, nausea, vomiting, diarrhea, or mucositis.

• Patients with programming to receive at least 3 cycles of anti-neoplastic chemotherapy;

• Patients may be on radiotherapy

Exclusion Criteria:

• Use of vitamin complex or concomitant food supplement;

• Current use or programming of parenteral diet use;

• Hypersensitivity to the components of the formula;

• Participation in another clinical study or use of any investigational product within 28 days prior to commencement of treatment in this clinical trial, unless the Investigator deems there to be a clinical benefit therefore;

Related Conditions & MeSH terms

• Cancer
• Chemotherapy Effect
• Quality of Life
• Thiamine
• Tryptophan

Intervention

Drug:
• TK3
Tryptophan and thiamine as on oral supplement

Locations

Country	Name	City	State
Brazil	Faculdade de medicina do ABC-CEPHO	Santo André	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View Citation

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. Epub 2005 Sep 12. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Portuguese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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