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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
140
Tryptophan and thiamine as on oral supplement
Faculdade de medicina do ABC-CEPHO
Santo André, São Paulo, Brazil
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
Time frame: 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
Time frame: It depends on the chemotherapy schedule: 14 or 21 days
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
Time frame: 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
Time frame: It depends on the chemotherapy schedule: 14 or 21 days
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