Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive
      and emotional functions.
    

Detailed description: 
      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.

      The preparation of the homeopathic treatment (sugar globule containing the homeopathic
      dilution) is held in a licensed pharmacy and according to the Israeli Ministry of Health
      instructions of preparation. Sixty globules of sugar are wetted in the final diluted solution
      and dried for several minutes, and will be packed in the pharmacy to be consumed by the
      patients 3 times a day, 15 minutes before meal.

      Placebo treatment is 1% sugar globule, similar in form and hedonic value of the
      aforementioned homeopathic globule.

      During the 32-33 sessions of radiotherapy (third assessment), all patients will be
      re-assessed for the third time as before (i.e. first and second assessments). A fourth
      assessment to be held one month after the completion of radiotherapy.
    

Intervention name(s): Homeopathy remedy; Radiation as adjuvant therapy for breast cancer
Intervention type(s): Other; Radiation
Intervention description(s): Homeopathy remedy, prescribed by a physician and prepared by licensed pharmacy.; Daily radiation therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment