Indolent LymphomaNCT04957693
Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period
A study testing vegan diet and lifestyle changes in people with Indolent Lymphoma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Lymphoma
- What is being tested?
- vegan diet and lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Jul 2021to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv
Irit Avivi, Prof', 03-6943782, iritavi@tlvmc.gov.il
Ella Krayzler, 03-6947395, ellakr@tlvmc.gov.il
About this study
Official title: Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period
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
- Being tested
- vegan diet and lifestyle changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegan diet and lifestyle changesBehavioural
vegan diet and lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | vegan diet and lifestyle change Receives: Behavioral: vegan diet and lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 36 months
Partial remission or complete remission
Response will be assessed by the revised Lugano classification
Measured: up to 36 months
Secondary outcomes (2)
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.
Measured: 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
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start5 Jul 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent LymphomaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- KaMaH - The Center for Health-Promoting Therapies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957693
- Sponsor's protocol ID
- 0264-18
- Status last verified
- Apr 2023
- First submitted
- 5 Jul 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period
- ClinicalTrials.gov ID
- NCT04957693
- Acronym / sponsor ID
- 0264-18
- Conditions
- Indolent Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- KaMaH - The Center for Health-Promoting Therapies
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Behavioral: vegan diet and lifestyle changesvegan diet and lifestyle change |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vegan diet and lifestyle changesvegan diet and lifestyle changes | Behavioural | treatment arm |
Primary outcome
Overall Response Rate
Time frame: 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
Partial remission or complete remission
Time frame: up to 36 months
Response will be assessed by the revised Lugano classification
2 secondary outcomes
Disease Free Survival
Time frame: up to 36 months
Progression Free Survival
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Indolent Lymphoma
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Active, not recruitingPhase 1/2
A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma, Marginal Zone Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 2/3
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vegan diet and lifestyle changes in people with Indolent Lymphoma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irit Avivi, Prof' (03-6943782, iritavi@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.