The Effect of an Oral Supplement,TK3 (Tryptophan and Thiamine) on the Quality of Life and Chemotherapy Tolerance in Cancer Patients With Advanced Disease. (TK3bFIIABC)

ABC Foundation (FUABC)

Status and phase

Unknown

Phase 2

Conditions

Chemotherapy Effect

Quality of Life

Tryptophan

Cancer

Thiamine

Treatments

Drug: TK3

Study type

Interventional

Funder types

Other

Identifiers

NCT03341286

TK3b FII ABC

Details and patient eligibility

About

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.

Full 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 .

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;