Recruiting

Observational Study

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT06047626

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fatigue Reduction Diet

General Health Curriculum

Study Details

Brief 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

Study ID

NCT06047626

Start date

Mar 7, 2024

Status verified date

Oct, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Fatigue Reduction Diet- FRD

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

active comparator: General Health Curriculum- GHC

3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC)

Interventions

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.

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 measure

  • Brief Fatigue Inventory [ Time Frame: 3 months after enrollment ]

Central Contacts and Locations

Central contacts

Sara Snyder

734-998-7124fammed-szickstudy@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sara Snyder

734-998-7124fammed-szickstudy@med.umich.edu

Principal Investigator:

Suzie Zick

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2025-10-30.