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

Indolent Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957693
• Other study ID #: 0264-18
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2023
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Irit Avivi, Prof'
• Phone: 03-6943782
• Email: iritavi[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Indolent Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	KaMaH - The Center for Health-Promoting Therapies

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Partial remission or complete remission	Response will be assessed by the revised Lugano classification	up to 36 months
Secondary	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
Secondary	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	up to 36 months