A Feasibility, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of 'Encer' on Cancer Treatment Related Fatigue
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Adverse Event (AE) or Serious Adverse Events (SAE)
研究概览
简要总结
This is a feasibility, double blind, placebo-controlled clinical study designed to evaluate the effect of 'Encer' on Cancer treatment Related Fatigue.
'Encer' is a combination of 5 Homeopathic Medical Product (HMP). The five HMPs are registered in the Homeopathic Pharmacopeia of the United States and the current investigational treatment 'Encer' is authorized for over-the-counter sales in the USA by NDC number.
The study aims to test the efficacy of 'Encer' in treating Cancer Treatment-Related Fatigue (CTRF) among cancer patients treated with chemotherapy and or radiotherapy using the Physiological measurements using Garmin vivosmart 5 and the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F).
This feasibility study will include patients that will be randomly assigned to either Placebo or Treatment in 1:1 ratio.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject's informed consent
- •Either male or female
- •Age 18 and above
- •Diagnosed with cancer (any type of solid tumor)
- •Patients planned for their initial treatment or a new regimen of chemotherapy, (at least 4 treatments planned within 12 weeks) a new regimen of radiotherapy (at least 15 fractions planned)
- •Able to interface with digital questionnaire sent to the patient electronically
- •Willing to wear a smartwatch that will detect physiological measurements for the duration of the trial
- •Not currently treated with homeopathic remedy (for at least one week prior to study treatment)
排除标准
- •Unable to give informed consent
- •Planned Radiotherapy for less than 15 fractions
- •Chemotherapy anticipated for less than 12 weeks, or fewer than 4 treatments
- •Life expectancy of less than 3 months
- •Patient is a dependent of the sponsor, of the investigational team or his/her immediate family
- •Pregnant or nursing women
结局指标
主要结局
Adverse Event (AE) or Serious Adverse Events (SAE)
时间窗: Weekly assessment from baseline until the end of the study at 12 weeks
Adverse Event means any untoward medical occurrence associated with the treatment, whether considered related or not. An Adverse Event (AE) is any untoward medical occurrence in a subject exposed to the treatment, whether it is related to the treatment in question or not. This includes a change in a subject's condition, which has or could have a deleterious effect on the subject's health or well-being. Chemotherapy induced AE are anticipated, and therefore any regular, possible common AE of chemotherapy such as nausea, diarrhea, mucositis, anemia, neutropenia, neuropathy or redness over the irradiated skin will be attributed to the systemic oncologic therapy.
次要结局
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Weekly assessment from baseline until the end of the study at 12 weeks)