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

Phase 2

• Conditions: Chemotherapy Effect; Cancer; Tryptophan; Thiamine; Quality of Life
• Interventions: Drug: TK3

• Registration Number: NCT03341286
• Lead Sponsor: Faculdade de Medicina do ABC

Brief 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.

Detailed 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 .

Study Timeline

• Study First Submitted: 2017-09-22
• Status Verified: 2017-10
• Study Start: 2017-11
• Study First Submitted QC: 2017-11-10
• Last Update Submitted: 2017-11-10
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14
• Primary Completion: 2019-01
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TK3	TK3	This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day
Placebo	TK3	Placebo orally, to be taken three times a day

Primary Outcome Measures

Name	Time	Method
The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy	It depends on the chemotherapy schedule: 14 or 21 days	use of quality of life questionaire FACIT-F

Secondary Outcome Measures

Name	Time	Method
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	It depends on the chemotherapy schedule: 14 or 21 days	use of CTCAE scale of adverse events v 4.0 and Edmonton scale
Drugs safety according to CTCAE scale of adverse events v 4.0	It depends on the chemotherapy schedule: 14 or 21 days	safety and tolerability

Trial Locations

Locations (1)

Faculdade de medicina do ABC-CEPHO; 🇧🇷 Santo André, SP, Brazil