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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03341286

Acronym

TK3bFIIABC

Enrollment

140

Registered

2017-11-14

Start date

2017-11-30

Completion date

2019-05-31

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chemotherapy Effect, Quality of Life, Thiamine, Tryptophan

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 quality of life and enhance adverse affects of chemotherapy in cancer patients.

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 .

Interventions

DRUGTK3

Tryptophan and thiamine as on oral supplement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Randomized, placebo-controlled

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026