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

Not Applicable

Recruiting

• Conditions: Indolent Lymphoma
• Interventions: Behavioral: vegan diet and lifestyle changes

• Registration Number: NCT04957693
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-05
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	vegan diet and lifestyle changes	vegan diet and lifestyle change

Primary Outcome Measures

Name	Time	Method
Partial remission or complete remission	up to 36 months	Response will be assessed by the revised Lugano classification
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

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel