Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period

Tel-Aviv Sourasky Medical Center (Other)
Overall Status
CT.gov ID
KaMaH - The Center for Health-Promoting Therapies (Other)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: vegan diet and lifestyle changes

Study Design

Study Type:
Anticipated Enrollment :
40 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period
Actual Study Start Date :
Jul 5, 2021
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

vegan diet and lifestyle change

Behavioral: vegan diet and lifestyle changes
vegan diet and lifestyle changes

Outcome Measures

Primary Outcome Measures

  1. Overall Response Rate [up to 36 months]

    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

  2. Partial remission or complete remission [up to 36 months]

    Response will be assessed by the revised Lugano classification

Secondary Outcome Measures

  1. Disease Free Survival [up to 36 months]

    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.

  2. Progression Free Survival [up to 36 months]

    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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Age ≥ 18 years old

  • Patient sex - male and female

  • Diagnosis with indolent lymphoma in low-grade lymphoma (follicular lymphoma (FL), marginal zone lymphoma MZL), as assessed by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria

  • Lack of need and non treatable patients at the time of diagnosis

  • Existence of detailed medical information about physical activity and dietary habits

  • Patients who have signed an informed consent form to participate in the study.

Exclusion Criteria:
  • Need for therapeutic intervention

  • Administration of chemotherapy and / or monoclonal antibodies or immunomodulatory preparation

  • Chronic inflammatory or infectious disease

  • Another malignant disease

  • Pregnant women, special populations - children and incapacitated of judgment

Contacts and Locations


Site City State Country Postal Code
1 Tel-Aviv Sourasky Medical Center Tel Aviv Israel

Sponsors and Collaborators

  • Tel-Aviv Sourasky Medical Center
  • KaMaH - The Center for Health-Promoting Therapies


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 0264-18
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021