Clinical trial NCT03341286: The Effect of an Oral Supplement,TK3 (Tryptophan and Thiamine) on the Quality of Life and Chemotherapy Tolerance in Cancer Patients With Advanced Disease.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer
Quality of Life
Chemotherapy Effect
Tryptophan
Thiamine
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled
Primary purpose: SUPPORTIVE_CARE

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 .

Eligibility criteria: 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;

Primary outcomes:
measure: The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy
timeFrame: It depends on the chemotherapy schedule: 14 or 21 days
measure: The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy
timeFrame: It depends on the chemotherapy schedule: 14 or 21 days
Secondary outcomes:
measure: 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
timeFrame: It depends on the chemotherapy schedule: 14 or 21 days
measure: Drugs safety according to CTCAE scale of adverse events v 4.0
timeFrame: It depends on the chemotherapy schedule: 14 or 21 days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de medicina do ABC-CEPHO
state: SP
Study officials:
References:
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