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| Name | Class |
|---|---|
| KaMaH - The Center for Health-Promoting Therapies | UNKNOWN |
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The aim of the present trial is to evaluate the effect of lifestyle changes on the natural history of indolent lymphomas, during the period of watchful waiting. The intervention program is comprised of specifically designed vegan nutrition, physical activity, mostly aerobic, and stress reduction by relaxation and meditation. Outcome results will be followed and analyzed for 3 years, taking into consideration the following parameters - disease burden, specific disease-related symptoms, relevant blood tests, body weight, indicators of well-being. Changes in these parameters will be correlated with the level of compliance and adherence to the intervention program. The results of the trial group of patients will be further compared to the natural history of the disease in a comparable group of patients during their waiting period who were not subject to the above intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | vegan diet and lifestyle change |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vegan diet and lifestyle changes | Behavioral | vegan diet and lifestyle changes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate (ORR) defined as the proportion of patients who achieve complete response (CR) and partial response (PR) determined by PET-CT imaging according to the 2014 Lugano criteria assessing FDG-PET/CT in lymphoma | up to 36 months |
| Partial remission or complete remission | Response will be assessed by the revised Lugano classification | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Disease-free survival defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause. | up to 36 months |
| Progression Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irit Avivi, Prof' | Contact | 03-6943782 | iritavi@tlvmc.gov.il | |
| Ella Krayzler | Contact | 03-6947395 | ellakr@tlvmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
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The time from the start of treatment to the date of the first documented disease progression or death due to any cause. Based on blood tests, physical exams and Positron Emission Tomography Computed Tomography (PET -CT) Lugano classification
| up to 36 months |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |