A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the trajectory of their disease. Treatment interventions for cancer-related fatigue have been largely unsuccessful. Homeopathy involves treatment of patients with diluted natural substances aimed at stimulating the body's healing system. In the efficacy trial literature, individualized homeopathy shows the most promise over other forms of homeopathic intervention. Individualized homeopathic treatment involves a unique yet established method of case taking. During the consultation, the homeopath asks a series of broad questions to elicit subjective symptoms related to the patient's disease, their medical history, as well as particular characteristics (physical or psychological) related to the individual. This study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat their fatigue. This study hypothesizes that homeopathic treatment will effectively treat fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with any type of cancer. Patients may have newly diagnosed, relapsed or a second malignant disease.
- •Receiving any type of chemotherapy administered intermittently (i.e. not continuous administration) with or without radiation treatment
- •Discharge from SickKids is anticipated to occur following completion of the current inpatient chemotherapy or chemotherapy is being administered as an outpatient
- •Between 2 and 18 years of age (age range for which instruments are available and children may be able to comply with homeopathy) A score on the Symptoms Distress Scale (SDS) of 2 or higher
- •Able to ingest medications in lactose/sucrose globule or liquid form
- •Reside within Greater Toronto area or willing to travel to the Riverdale Homeopathic Clinic. Participants living outside of the Greater Toronto area who wish to receive home visits may be eligible provided that permission is granted by the homeopath investigator
- •A parent or caregiver must be able to read and write in English.
- •Patients who are currently receiving CAM including homeopathy are eligible.
排除标准
- •Previous history of allergy to the homeopathic products
研究组 & 干预措施
Sublingual or Oral Liquid Homeopathy
The homeopathic remedy will be administered as 1 lactose/sucrose globule 2.5 mm in diameter to be administered sublingually up to 3 times per day or as 0.2 ml of a 30% ethanol based liquid homeopathic remedy administered orally up to 3 times per day. The homeopathic remedy and/or the homeopathic remedy potency can be changed on a daily basis during the course of treatment. However, only one homeopathic remedy and potency will be administered at a given time.
干预措施: Homeopathic Remedies (Other)
结局指标
主要结局
Feasibility of recruitment
时间窗: baseline
The primary objective is to determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.
次要结局
- Feasibility of administration(14 days)
- Changes in fatigue(Change from baseline to 14 days)
- Changes in quality of life(Change from baseline to 14 days)
研究者
Lillian Sung
Staff Physician
The Hospital for Sick Children