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NCT Number: NCT05839210

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

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.

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Key information

Conditions

Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • BR
  • BV-AVD or ABVD or checkpoint inhibitor+AVD
  • ECOG Performance Status grade of <2

a. 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.

Exclusion criteria

  • 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

Treatment and study plan

LIFE-L Mediterranean Diet

Behavioral

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 Program

Behavioral

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 Materials

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Average Relative Dose Intensity (RDI)

    Time frame: Up to 30 weeks

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)

Acronym: LIFE-L

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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