Breast Cancer Clinical Trial
Official title:
Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions.
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.
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