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Living Well with Lymphoma: A Randomized Trial Improving Diet Quality to Improve Energy, Sleep and Quality of Life

Primary Investigator
Zick, Suzie
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT06047626
UM Number
2023.015
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
45815
Secondary Protocol No
HUM00230256
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
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.

Eligibility: Inclusion Criteria
  •   Women and men aged 18 years and older
  •   Diagnosis of DLBCL treated with R-CHOP or R-EPOCH
  •   Have an average persistent fatigue defined as >= 4 on the Brief Fatigue Inventory
  •   Fatigue must have started at or after the diagnosis of DLBCL
  •   Completed all primary cancer treatments (e.g., chemotherapy) between 6 months to 2 years prior
  •   Have no evidence of DLBCL disease progression
  •   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
  •   BMI18.5 or >35 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