Assessment of Quality of Life and the Toxicity of Chemotherapy in Patients With Malignancies in Clinical Stages III and IV Under Palliative Treatment With Chemotherapy or Hormone Therapy With or Without Nutritional Supplement TK3
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of Quality of Life
研究概览
简要总结
The association of nutritional supplement TK3 to conventional treatment of cancer patients reduces the intensity and frequency of toxic effects and side effects caused by adjuvant or palliative treatments for the protection of healthy tissues, resulting in a better quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Consent: Informed Consent and informed consent signed and dated by the patient (or his legal representative) and the professional who has obtained the consent. Must be delivered before inclusion. This term must be read and explained to the patient.
- •Patients female or male, regardless of race or color.Able to ingest oral medication.
- •Patients 30-80 years, with malignancy, clinical stage III or IV on chemo or hormone therapy.
- •Patients who have a Karnofsky level between 60 and 80.
排除标准
- •no agreement to sign the Deed of Consent.
- •Need for use of parenteral nutrition.
- •The need for food supplement already approved.
- •Inability to receive the drug orally.
- •Participation in another clinical trial involving chemotherapy drugs.
- •Women being sexually active, which does not agree to adhere to the contraceptive methods adopted.
- •Women lactating
- •Any problem or condition that the investigator in the trial could be harmful to the patient.
研究组 & 干预措施
Placebo
干预措施: 1 capsule, 3 times per day (Dietary Supplement)
TK3
1 capsule, 3 times per day.
干预措施: TK3 (Dietary Supplement)
结局指标
主要结局
Assessment of Quality of Life
时间窗: 180 days
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
Assessment of Quality of Life
时间窗: 0 day
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
Assessment of Quality of Life
时间窗: 30 days
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
Assessment of Quality of Life
时间窗: 60 days
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
Assessment of Quality of Life
时间窗: 90 days
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
Assessment of Quality of Life
时间窗: 120 days
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
Assessment of Quality of Life
时间窗: 150 days
Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3.
次要结局
- Performance status(0 day)
- Performance Status(180 days)
- Perfomance status(30 days)
- Tumor Markers(180 day)
- Performance Status(60 days)
- Performance Status(90 days)
- Performance Status(120 days)
- Performance Status(150 days)
- Tumor Markers(0 day)
- Tumor Markers(30 day)
- Tumor Markers(60 day)
- Tumor Markers(90 day)
- Tumor Markers(120 day)
- Tumor Markers(150 day)