Status:
UNKNOWN
The Effect of an Oral Supplement,TK3 (Tryptophan and Thiamine) on the Quality of Life and Chemotherapy Tolerance in Cancer Patients With Advanced Disease.
Lead Sponsor:
Faculdade de Medicina do ABC
Conditions:
Cancer
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 qu...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03341286
Start Date
November 1 2017
End Date
May 1 2019
Last Update
November 14 2017
Active Locations (1)
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1
Faculdade de medicina do ABC-CEPHO
Santo André, São Paulo, Brazil, 09060-870