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| Name | Class |
|---|---|
| Technion, Israel Institute of Technology | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy with Homeopathy | Experimental | 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. |
|
| Radiation therapy with placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Homeopathy remedy | Other | Homeopathy remedy, prescribed by a physician and prepared by licensed pharmacy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physiological monitoring of changes in anxiety during radiotherapy with and without homeopathy treatment. | Attention performance will be assessed by the Pre-Pulse Inhibition (PPI) task by evaluating the startle response test an Galvanic Skin Response differences. | Days 1, 16, 33 of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological monitoring of changes in attention during radiotherapy with and without homeopathy treatment. | An interview assessing the changes attention with the Fatigue Symptom Inventory scale. | Days 1, 16, 33 of radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merav Ben-David, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merav Ben David | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34027702 | Derived | Dolev T, Ben-David M, Shahadi I, Freed Y, Zubedat S, Aga-Mizrachi S, Brand Z, Galper S, Jacobson G, Avital A. Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019470. doi: 10.1177/15347354211019470. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Radiation as adjuvant therapy for breast cancer | Radiation | Daily radiation therapy. |
|
| D017437 |
| Skin and Connective Tissue Diseases |