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

Primary Purpose

Indolent Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
vegan diet and lifestyle changes
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

vegan diet and lifestyle change

Outcomes

Primary Outcome Measures

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
Partial remission or complete remission
Response will be assessed by the revised Lugano classification

Secondary Outcome Measures

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.
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

Full Information

First Posted
July 5, 2021
Last Updated
April 20, 2023
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
KaMaH - The Center for Health-Promoting Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT04957693
Brief Title
Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period
Official Title
Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
KaMaH - The Center for Health-Promoting Therapies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
vegan diet and lifestyle change
Intervention Type
Behavioral
Intervention Name(s)
vegan diet and lifestyle changes
Intervention Description
vegan diet and lifestyle changes
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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
Title
Partial remission or complete remission
Description
Response will be assessed by the revised Lugano classification
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
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
Title
Progression Free Survival
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irit Avivi, Prof'
Phone
03-6943782
Email
iritavi@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ella Krayzler
Phone
03-6947395
Email
ellakr@tlvmc.gov.il
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irit Avivi, Prof'
Phone
03-6943782
Email
iritavi@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Ella Krayzler
Phone
03-6947395
Email
ellakr@tlvmc.gov.il

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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