Living Well With Lymphoma

NCT06047626 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-30

No results posted yet for this study

Summary

In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a \~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.

Conditions

Lymphoma

Interventions

OTHER

Fatigue Reduction Diet

Sessions will be \~15 minutes for 8 sessions. The FRD maintains participants on a diet with their typical caloric intake as assessed at baseline, and replaces some of their calories with the following foods on a daily basis: at least 50% of servings grains to be whole grains (these would replace non-whole grain foods); 5 servings of vegetables (1 leafy green, 1 tomato, and 1 yellow/orange); 2 servings of fruit (1 high in vitamin C), both fruit and vegetables would replace some of the carbohydrates from non-fruit and vegetable sources; 1 serving of fatty fish and or 1 serving of nuts and/or seeds (2 servings of nuts and/or seeds for vegetarians), both the fish, the nuts, and seeds will replace existing sources of fats and proteins in the diet.

OTHER

General Health Curriculum

These sessions will be matched counseling method, time spent (\~15 minutes per session), for 8 sessions. Registered Dietitians will discuss general health topics with the participant, excluding topics of diet and food.

Sponsors & Collaborators

American Institute for Cancer Research
collaborator OTHER
University of Michigan Rogel Cancer Center
lead OTHER

Principal Investigators

Suzie Zick · University of Michigan Rogel Cancer Center

Study Design

Allocation: RANDOMIZED
Purpose: SUPPORTIVE_CARE
Masking: NONE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2024-03-07
Primary Completion: 2027-09-30
Completion: 2028-09-30

Countries

United States

Study Locations

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Entities

Diseases

Lymphoma