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

NCT04957693 | Unknown

• 1 other identifier: 0264-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Indolent Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Disease Free Survival

  up to 36 months

• Progression Free Survival

  up to 36 months

Study Arms (1)

treatment arm

EXPERIMENTAL

vegan diet and lifestyle change

Behavioral: vegan diet and lifestyle changes

Interventions

vegan diet and lifestyle changes BEHAVIORAL

vegan diet and lifestyle changes

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

Diet, Vegan

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Irit Avivi, Prof'

CONTACT

03-6943782; iritavi@tlvmc.gov.il

Ella Krayzler

CONTACT

03-6947395; ellakr@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 12, 2021
• Study Start: July 5, 2021
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

IL (1)