Living Well With Lymphoma

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Lymphoma

Treatments: Other: Fatigue Reduction Diet; Other: General Health Curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT06047626

HUM00230256 (Other Identifier)

UMCC 2023.015

Details and patient eligibility

About

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.

Full description

26OCT2025- Overall enrollment increased to 100

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Fatigue Reduction Diet- FRD

Experimental group

Description:

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

Treatment:

Other: Fatigue Reduction Diet

General Health Curriculum- GHC

Active Comparator group

Description:

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

Treatment:

Other: General Health Curriculum