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

Tel-Aviv Sourasky Medical Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Indolent Lymphoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 36 months

Partial remission or complete remission

Response will be assessed by the revised Lugano classification

Time frame: up to 36 months

Secondary Outcomes

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.

Time frame: up to 36 months

Progression Free Survival

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

Time frame: up to 36 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts