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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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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.

Conditions
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Cancer, Quality of Life, Chemotherapy Effect, Tryptophan, Thiamine

Intervention / Treatment
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* Drug: TK3


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TK3<br>This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day | Drug: TK3<br>* Tryptophan and thiamine as on oral supplement<br>|
| Placebo Comparator: Placebo<br>Placebo orally, to be taken three times a day | Drug: TK3<br>* Tryptophan and thiamine as on oral supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |