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

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faculdade de Medicina do ABC
• Treatments: Thiamine; Tryptophan

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;