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)

November 10, 2017 updated by: Daniel de Iracema Gomes Cubero, Faculdade de Medicina do ABC

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Santo André, SP, Brazil, 09060-870
        • Faculdade de medicina do ABC-CEPHO
        • Contact:
        • Sub-Investigator:
          • Claudia VM Sette, MD
        • Sub-Investigator:
          • Aline APR Lima, MD
        • Sub-Investigator:
          • Auro Del giglio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TK3
This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day
Drug: TK3
Tryptophan and thiamine as on oral supplement
Placebo Comparator: Placebo
Placebo orally, to be taken three times a day
Drug: TK3
Tryptophan and thiamine as on oral supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy
Time Frame: It depends on the chemotherapy schedule: 14 or 21 days
use of quality of life questionaire QLQ-C30
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
Time Frame: It depends on the chemotherapy schedule: 14 or 21 days
use of quality of life questionaire FACIT-F
It depends on the chemotherapy schedule: 14 or 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: It depends on the chemotherapy schedule: 14 or 21 days
use of CTCAE scale of adverse events v 4.0 and Edmonton scale
It depends on the chemotherapy schedule: 14 or 21 days
Drugs safety according to CTCAE scale of adverse events v 4.0
Time Frame: It depends on the chemotherapy schedule: 14 or 21 days
safety and tolerability
It depends on the chemotherapy schedule: 14 or 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • TK3b FII ABC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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