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

NCT03341286 | Unknown Phase 2 DMC

• 1 other identifier: TK3b FII ABC
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  It depends on the chemotherapy schedule: 14 or 21 days

Secondary Outcomes (2)

• 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

• Drugs safety according to CTCAE scale of adverse events v 4.0

  It depends on the chemotherapy schedule: 14 or 21 days

Study Arms (2)

TK3

EXPERIMENTAL

This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day

Drug: TK3

Placebo

PLACEBO COMPARATOR

Placebo orally, to be taken three times a day

Drug: TK3

Interventions

TK3 DRUG

Tryptophan and thiamine as on oral supplement

Placebo; TK3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

Faculdade de medicina do ABC-CEPHO

Santo André, São Paulo, 09060-870, Brazil

Location

Related Publications (11)

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  PMID: 20832987 BACKGROUND

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  PMID: 1714502 BACKGROUND

• Monteiro Dda R, Almeida Mde A, Kruse MH. [Translation and cross-cultural adaptation of the Edmonton Symptom Assessment System for use in Palliative Care]. Rev Gaucha Enferm. 2013 Jun;34(2):163-71. doi: 10.1590/s1983-14472013000200021. Portuguese.

  PMID: 24015476 BACKGROUND

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  PMID: 21098316 BACKGROUND

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  PMID: 26567010 BACKGROUND

• Curran D, Pozzo C, Zaluski J, Dank M, Barone C, Valvere V, Yalcin S, Peschel C, Wenczl M, Goker E, Bugat R. Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial. Qual Life Res. 2009 Sep;18(7):853-61. doi: 10.1007/s11136-009-9493-z. Epub 2009 Jul 1.

  PMID: 19568958 BACKGROUND

• Brown J, Thorpe H, Napp V, Fairlamb DJ, Gower NH, Milroy R, Parmar MK, Rudd RM, Spiro SG, Stephens RJ, Waller D, West P, Peake MD. Assessment of quality of life in the supportive care setting of the big lung trial in non-small-cell lung cancer. J Clin Oncol. 2005 Oct 20;23(30):7417-27. doi: 10.1200/JCO.2005.09.158. Epub 2005 Sep 12.

  PMID: 16157935 BACKGROUND

• Southwest Oncology Group; Berry DL, Moinpour CM, Jiang CS, Ankerst DP, Petrylak DP, Vinson LV, Lara PN, Jones S, Taplin ME, Burch PA, Hussain MH, Crawford ED. Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. J Clin Oncol. 2006 Jun 20;24(18):2828-35. doi: 10.1200/JCO.2005.04.8207.

  PMID: 16782921 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Model Details: Randomized, placebo-controlled

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: November 14, 2017
• Study Start: November 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 14, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)