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Trial Title:
Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
NCT ID:
NCT05839210
Condition:
Non Hodgkin Lymphoma
Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Mediterranean Diet
Exercise Program
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
LIFE-L Mediterranean Diet
Description:
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.
Arm group label:
LIFE-L Group
Intervention type:
Behavioral
Intervention name:
LIFE-L Home-Based Exercise Program
Description:
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.
Arm group label:
LIFE-L Group
Intervention type:
Behavioral
Intervention name:
Supportive Materials
Description:
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.
Arm group label:
Control Group
Arm group label:
LIFE-L Group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tracy E Crane, PhD, RDN
Phone:
305-243-8255
Email:
tecrane@med.miami.edu
Investigator:
Last name:
Tracy E Crane, PhD, RDN
Email:
Principal Investigator
Investigator:
Last name:
Craig Moskowitz, MD
Email:
Principal Investigator
Start date:
April 26, 2023
Completion date:
April 26, 2025
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05839210
