Breast Cancer Clinical Trial
Official title:
Cognitive and Emotional Assessment of Fatigue During Radiotherapy for Breast Cancer With and Without Homeopathy Treatment
NCT number | NCT02890316 |
Other study ID # | 2370-15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | August 1, 2018 |
Verified date | April 2019 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive and emotional functions.
Status | Completed |
Enrollment | 64 |
Est. completion date | August 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Female patients aged at least 18 years with unilateral breast cancer following chemotherapy. 2. Planned to receive 50 Gy whole breast irradiation and lymphatic basin + boost to tumor bed. 3. Capable of giving written informed consent following the instructions of receiving the study remedy or placebo. 4. No co-morbidities known to affect radiotherapy reactions. 5. No co-existing neurological or active psychiatric chronic diseases. 6. No evidence of infection or inflammation of breast to be treated. 7. Not receiving chemotherapy during radiotherapy course. Biological or hormonal therapy will be allowed during the study. Exclusion Criteria: 1. Uncontrolled hypertension. 2. Participating in another clinical study with active treatment 3. Substance abuse. 4. Intellectual disabilities. 5. Unable to sign informed concent |
Country | Name | City | State |
---|---|---|---|
Israel | Merav Ben David | Ramat-Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center | Technion, Israel Institute of Technology |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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