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.
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
研究组 & 干预措施
TK3
This is a oral supplement combination of tryptophan and thiamine called TK3 to be taken three times a day
干预措施: TK3 (Drug)
Placebo
Placebo orally, to be taken three times a day
干预措施: TK3 (Drug)
结局指标
主要结局
The role of TK3 in the quality of life of patients receiving anti-neoplastic chemotherapy after 3 cicles of chemotherapy
时间窗: It depends on the chemotherapy schedule: 14 or 21 days
use of quality of life questionaire FACIT-F
次要结局
- 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)
研究者
Daniel de Iracema Gomes Cubero
PHD
Faculdade de Medicina do ABC