Menu
Recruiting NCT06047626

Living Well With Lymphoma

No phase Interventional Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fatigue Reduction Diet, General Health Curriculum.
Who it may be relevant to
Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life

Overview

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.

Detailed description

26OCT2025- Overall enrollment increased to 100

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 carbohydrat
  • 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.

Primary outcome measures

  • Brief Fatigue Inventory [Time frame: 3 months after enrollment]
Secondary outcome measures (8)
  • Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life [Time frame: 3 months after enrollment]
  • The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance [Time frame: 3 months after enrollment]
  • The effect of 3 months of FRD compared to an attention control GHC on persistent pain [Time frame: 3 months after enrollment]
  • The effect of 3 months of FRD compared to an attention control GHC on persistent mood [Time frame: 3 months after enrollment]
  • The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function [Time frame: 3 months after enrollment]
  • Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program [Time frame: 3 months after enrollment]
  • Examining the acceptability of the FRD program- FRD initiation [Time frame: 3 months after enrollment]
  • Number of subjects who withdraw from study (acceptability) [Time frame: 3 months after enrollment]

Eligibility criteria

Inclusion criteria

  • Women and men aged 18 years and older
  • Diagnosis of lymphoma (Hodgkin and non-Hodgkin)
  • Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory
  • Fatigue must be attributed to lymphoma diagnosis
  • Fatigue onset must be between 12months before diagnosis and any time after diagnosis
  • Fatigue must not be attributed to other disease diagnoses
  • Fruit and vegetable intake ≤5.5 servings/day
  • Have, or be willing to create, an email address to receive study questionnaires electronically.

Exclusion criteria

  • Medically unstable
  • BMI<18.5 kg/m2
  • Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder
  • Have a current untreated diagnosis of anemia
  • Have a current untreated diagnosis of hypothyroidism
  • Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study
  • Have a current diagnoses of cachexia
  • Planning on becoming pregnant, currently pregnant or lactating

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT06047626 · UMCC 2023.015 · HUM00230256

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗