MedPath

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

Not Applicable
Recruiting
Conditions
Non Hodgkin Lymphoma
Hodgkin Lymphoma
Registration Number
NCT05839210
Lead Sponsor
University of Miami
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
Inclusion Criteria
  1. 18 years of age or older

  2. Any sex/gender

  3. Able to provide consent

  4. Able to read or understand English or Spanish

  5. 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:

    1. R-CHOP or R-CHOP-like regimen
    2. BR
    3. BV-AVD or ABVD or checkpoint inhibitor+AVD
  6. ECOG Performance Status grade of <2

    a. PI approval needed if ECOG = 2

  7. Approval from treating oncologist, confirmed via email or in writing

  8. Delivery of chemotherapy treatments at one of the following institutions:

    1. Sylvester Comprehensive Cancer Center (including satellite/network sites)
    2. University of Miami Hospital/UHealth Tower
  9. Internet access on a smart phone, tablet, or computer

  10. Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Exclusion Criteria
  1. Individuals younger than 18 years of age
  2. Unable to provide consent
  3. Unable to read or understand English or Spanish
  4. Any contraindication for diet change or exercising as determined by physician
  5. Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
  6. Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
  7. History of dementia or major psychiatric disease
  8. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Completing Intervention SessionsUp 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 satisfaction4 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.

Percentage of Survivors who participateUp 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.

Secondary Outcome Measures
NameTimeMethod
Average Relative Dose Intensity (RDI)Up to 30 weeks

RDI will be assessed using a threshold of greater than or equal to (\>=) 80-percent.

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

University of Miami
🇺🇸Miami, Florida, United States
Tracy E Crane, PhD, RDN
Principal Investigator
Craig Moskowitz, MD
Principal Investigator

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