Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Physiological monitoring of changes in anxiety during radiotherapy with and without homeopathy treatment.
研究概览
简要总结
To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions.
详细描述
Sixty four female patients who underwent Chemotherapy and are planned to receive adjuvant whole breast radiation in the radiation departmental at the Sheba Medical Center, and who give a written consent for participation, will be included in the study.
Patients will undergo routine CT simulation and will receive 50 Gy in daily fractions of 2 Gy, five times a week (for total of 33 sessions during ~7 weeks, including boost of 8 fractions to the tumor bed) to the whole breast and lymphatic basins, according to the standard departmental protocol. Demographic and cancer treatment information will be collected, as well as Body mass index (BMI). At the first RT session (first assessment) and following 16-20 sessions of radiotherapy (second assessment), all patients will be evaluated for:
(i) fatigue level utilizing the Fatigue Symptom Inventory (FSI). (ii) attention performance utilizing the Pre-Pulse Inhibition (PPI) task. (iii) anxiety level utilizing both the startle response test and examining the Galvanic Skin Response (GSR) differences.
All examination will be conducted after the daily radiotherapy session. The homeopathic doctor will conduct an individual homeopathic evaluation during the second assessment meeting to all participants. According to these assessments, the pharmacist will prepare and provide 64 blinded numbered sets, 40 of which will contain the study remedy and 24 will contain the carrier only (i.e placebo).
Upon entry to the study after meeting the exclusion/inclusion criteria, a number from 1-64 will be drawn and the patient will receive the corresponding treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged at least 18 years with unilateral breast cancer following chemotherapy.
- •Planned to receive 50 Gy whole breast irradiation and lymphatic basin + boost to tumor bed.
- •Capable of giving written informed consent following the instructions of receiving the study remedy or placebo.
- •No co-morbidities known to affect radiotherapy reactions.
- •No co-existing neurological or active psychiatric chronic diseases.
- •No evidence of infection or inflammation of breast to be treated.
- •Not receiving chemotherapy during radiotherapy course. Biological or hormonal therapy will be allowed during the study.
排除标准
- •Uncontrolled hypertension.
- •Participating in another clinical study with active treatment
- •Substance abuse.
- •Intellectual disabilities.
- •Unable to sign informed concent
研究组 & 干预措施
Radiation therapy with Homeopathy
Patients in this arm will receive the homeopathy remedy during the adjuvant radiation therapy period, from treatment number 16 until the last assessment, 3 times every day.
干预措施: Homeopathy remedy (Other)
Radiation therapy with Homeopathy
Patients in this arm will receive the homeopathy remedy during the adjuvant radiation therapy period, from treatment number 16 until the last assessment, 3 times every day.
干预措施: Radiation as adjuvant therapy for breast cancer (Radiation)
Radiation therapy with placebo
Patients in this arm will receive the placebo remedy during the adjuvant radiation period, from treatment number 16 until the last assessment, 3 times every day.
干预措施: Radiation as adjuvant therapy for breast cancer (Radiation)
结局指标
主要结局
Physiological monitoring of changes in anxiety during radiotherapy with and without homeopathy treatment.
时间窗: Days 1, 16, 33 of radiation therapy
Attention performance will be assessed by the Pre-Pulse Inhibition (PPI) task by evaluating the startle response test an Galvanic Skin Response differences.
次要结局
- Physiological monitoring of changes in attention during radiotherapy with and without homeopathy treatment.(Days 1, 16, 33 of radiation therapy)
研究者
Dr. Merav Ben-David
Head, Breast Radiation Unit
Sheba Medical Center
