The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer: a Randomized, Parallel-group, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Primary Objective: * The primary objective of the study is to explore the effect of LentinexHP versus placebo as an add-on non-drug therapy to improve QoL in patients with stage IVmetastatic colorectal cancer.
研究概览
简要总结
This is a randomized, double-blind parallel-group, placebo-controlled study. that will last 40 weeks and will focus on Quality of Life.36 Subjects with stage IV metastatic colorectal cancer will be referred for study inclusion. Patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days. The patients will periodically complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL study.
详细描述
This is a randomized, double-blind parallel-group, placebo-controlled study. Subjects with stage IV metastatic colorectal cancer identified by the Principal Investigator or other qualified oncologists will be referred for potential study inclusion.
* Baseline Visit (Week 1) After written informed consent and verification of eligibility criteria, patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days.
Patient demographics, blood chemistries, complete blood count (CBC), and vital signs, will be obtained from the patient's medical records and included as part of the study.
The patients will then complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL s
- Visit 2 (Week 6) After six weeks, patients will be asked to return to the clinic and return used/unused bottles of LentinexHP or placebo for compliance evaluation. Patients will evaluate their QoL over the first six weeks of supplementation through the FACT-C, SF-36, FSI and the QoL questionnaire used in a prior LentinexHP study assessing QoL. Any self-perceived adverse events (AE) will be discussed with the patient. The Investigator will also review cancer treatments, vital signs and blood data (if available) to assess for any changes that might have occurred over the first six-week period.
- Visit 3 (Week 12) Patients will return to the clinic with their used/unused bottles of LentinexHP or placebo and again fill out the various QoL questionnaires. As in Visit 2, cancer treatments, blood data and vital signs obtained from medical records will be reviewed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blinded, randomized study. Only the administering pharmacist will have access to the randomization tables
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
- •Signed written informed consent.
- •Age 18 years or older.
- •Male or female.
- •Patients with stage IV metastatic colorectal cancer with less than three metastatic sites.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patients starting on 1st or 2nd line chemotherapy with a 5-fluorouracil (5-FU) based regimen with or without biologics.
排除标准
- •Patients with known or suspected hypersensitivity to any of the components of the test food supplement.
- •Pregnant or breastfeeding.
- •Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (COVID-19 drugs recommended by local regulatory authorities are permitted).
- •Patients who in the opinion of the treating physician should not participate in this program.
- •Prisoners.
结局指标
主要结局
Primary Objective: * The primary objective of the study is to explore the effect of LentinexHP versus placebo as an add-on non-drug therapy to improve QoL in patients with stage IVmetastatic colorectal cancer.
时间窗: 12 Weeks
The primary Instrument to be used for evaluation of the QoL is a validated 27-item questionnaire (FACT-C) designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The FACT-C questionnaire assess the quality of life concerns pertinent to colorectal cancer patients.at weeks, 0 (baseline), 6 and 12. The scale has a numerical value from 0 to 9, where the rating of 0 means the patient feels worse than they did at a previous time point, and a rating of 9 means the patient feels much better than they did at a previous time point. Values between 0 and 9 reflect relative feelings on that day.
次要结局
- Secondary Objective (Outcome 2)* A secondary objective of this study is to evaluate the patients' self-perception of their overall health.(12 Weeks)