Non Hodgkin LymphomaLIFE-LNCT05839210
Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
A study testing LIFE-L Mediterranean Diet, LIFE-L Home-Based Exercise Program and Supportive Materials in people with Non Hodgkin Lymphoma and Hodgkin Lymphoma, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Hodgkin Lymphoma
- What is being tested?
- LIFE-L Mediterranean Diet, LIFE-L Home-Based Exercise Program and Supportive Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Any sex/gender
- Able to provide consent
- Able to read or understand English or Spanish
- Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:
- R-CHOP or R-CHOP-like regimen
Show all 16Show fewer
- BR
- BV-AVD or ABVD or checkpoint inhibitor+AVD
- ECOG Performance Status grade of <2
- PI approval needed if ECOG = 2
- Approval from treating oncologist, confirmed via email or in writing
- Delivery of chemotherapy treatments at one of the following institutions:
- Sylvester Comprehensive Cancer Center (including satellite/network sites)
- University of Miami Hospital/UHealth Tower
- Internet access on a smart phone, tablet, or computer
- Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.
Who cannot join
- Individuals younger than 18 years of age
- Unable to provide consent
- Unable to read or understand English or Spanish
- Any contraindication for diet change or exercising as determined by physician
- Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
- Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
- History of dementia or major psychiatric disease
- History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Tracy E Crane, PhD, RDN, 305-243-8255, tecrane@med.miami.edu
Tracy E Crane, PhD, RDN
About this study
Official title: Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)
The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.
- Conditions
- Non Hodgkin Lymphoma, Hodgkin Lymphoma
- Being tested
- LIFE-L Mediterranean Diet, LIFE-L Home-Based Exercise Program, Supportive Materials
- Keywords
- Mediterranean Diet, Exercise Program
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFE-L Mediterranean DietBehavioural
Mediterranean Diet will include goals of: 4+ vegetable servings (2-4 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week. Limit or avoid highly processed foods, sugar-sweetened beverages and foods, processed meats, red meat, and alcohol.
LIFE-L Home-Based Exercise ProgramBehavioural
The Home-Based Exercise Program will include goals of: 150+ minutes moderate or 75+ minutes vigorous exercise per week, completed in sessions of at least 10-minute duration, including daily aerobic exercise plus two resistance-based exercise sessions per week.
Supportive MaterialsBehavioural
Participants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages.
Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be provided by research staff. For participants who choose not to use the app, a laminated diet and exercise tracking sheet with dry erase marker will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to research staff each week.
| Study group | Role | What they receive |
|---|---|---|
| LIFE-L Group | Experimental | Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program. Receives: Behavioral: LIFE-L Mediterranean Diet; Behavioral: LIFE-L Home-Based Exercise Program; Behavioral: Supportive Materials |
| Control Group | Other | Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention. Receives: Behavioral: Supportive Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Survivors who participate
Percentage of survivors who agree to participate out of the total number of participants recruited will be assessed using a threshold of greater than or equal to (>=) 50-percent.
Measured: Up to 12 months
Percentage of Participants Completing Intervention Sessions
Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (>=) 80-percent.
Measured: Up to 26 weeks (Post-Intervention)
Change in percentage of participant satisfaction
The change in percentage of participant satisfaction rate at the end of study participation will be assessed, using a threshold of greater than or equal to (>=) 80-percent. Participant satisfaction will be assessed via exit interviews.
Measured: 4 weeks (post-intervention), up to 30 weeks
Secondary outcomes (1)
Average Relative Dose Intensity (RDI)
RDI will be assessed using a threshold of greater than or equal to (>=) 80-percent.
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start26 Apr 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy E Crane, PhD, RDN, University of Miami
- Investigators
- Tracy E Crane, Phd, RDN, Principal investigator, University of MiamiCraig Moskowitz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839210
- Sponsor's protocol ID
- 20221298
- Acronym
- LIFE-L
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)
- ClinicalTrials.gov ID
- NCT05839210
- Acronym / sponsor ID
- LIFE-L / 20221298
- Conditions
- Non Hodgkin Lymphoma, Hodgkin Lymphoma
- Keywords
- Mediterranean Diet, Exercise Program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 May 2023 (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 purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFE-L Group | Experimental | Behavioral: LIFE-L Mediterranean Diet, Behavioral: LIFE-L Home-Based Exercise Program, Behavioral: Supportive MaterialsParticipants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program. |
| Control Group | Other | Behavioral: Supportive MaterialsParticipants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18 years of age or older
- Any sex/gender
- Able to provide consent
- Able to read or understand English or Spanish
- Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:
Key exclusion criteria (8 listed)
- Individuals younger than 18 years of age
- Unable to provide consent
- Unable to read or understand English or Spanish
- Any contraindication for diet change or exercising as determined by physician
- Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
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 |
|---|---|---|
| LIFE-L Mediterranean DietMediterranean Diet will include goals of: 4+ vegetable servings (2-4 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week. Limit or avoid highly processed foods, sugar-sweetened beverages and foods, processed meats, red meat, and alcohol. | Behavioural | LIFE-L Group |
| LIFE-L Home-Based Exercise ProgramThe Home-Based Exercise Program will include goals of: 150+ minutes moderate or 75+ minutes vigorous exercise per week, completed in sessions of at least 10-minute duration, including daily aerobic exercise plus two resistance-based exercise sessions per week. | Behavioural | LIFE-L Group |
| Supportive MaterialsParticipants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages. Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be provided by research staff. For participants who choose not to use the app, a laminated diet and exercise tracking sheet with dry erase marker will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to research staff each week. | Behavioural | Control Group, LIFE-L Group |
Primary outcome
Percentage of Survivors who participate
Time frame: Up to 12 months
Percentage of survivors who agree to participate out of the total number of participants recruited will be assessed using a threshold of greater than or equal to (>=) 50-percent.
Percentage of Participants Completing Intervention Sessions
Time frame: Up to 26 weeks (Post-Intervention)
Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (>=) 80-percent.
Change in percentage of participant satisfaction
Time frame: 4 weeks (post-intervention), up to 30 weeks
The change in percentage of participant satisfaction rate at the end of study participation will be assessed, using a threshold of greater than or equal to (>=) 80-percent. Participant satisfaction will be assessed via exit interviews.
1 secondary outcome
Average Relative Dose Intensity (RDI)
Time frame: Up to 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Tracy E Crane, Phd, RDN principal investigator
University of Miami
Craig Moskowitz, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFE-L Mediterranean Diet, LIFE-L Home-Based Exercise Program and Supportive Materials in people with Non Hodgkin Lymphoma and Hodgkin Lymphoma, run by University of Miami at 1 site in United States.
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 16 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy E Crane, PhD, RDN (305-243-8255, tecrane@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Survivors who participate (time frame: Up to 12 months). The study lists 3 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 30 Jan 2026.