| NCT ID | NCT06047626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-07 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Suzie Zick
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT06047626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047626 currently recruiting?
Yes, NCT06047626 is actively recruiting participants. Contact the research team at fammed-szickstudy@med.umich.edu for enrollment information.
Where is the NCT06047626 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06047626 clinical trial?
NCT06047626 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Suzie Zick at University of Michigan Rogel Cancer Center. The trial plans to enroll 100 participants.