Clinical trial NCT05327725: Fatigue Reduction Diet in Lymphoma Survivors
Official title: Fatigue Reduction Diet in Survivors of Diffuse Large B-Cell Lymphomas; a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Large B-Cell, Diffuse
Fatigue
Keywords: fatigue reduction diet
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial of a fatigue reduction diet intervention among diffuse-large B-cell lymphoma (DLBCL) survivors. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing in 8 sessions over 3 months. Dietary intake and fatigue will be assessed at baseline and 3 months. The objective of the study is to determine feasibility of the intervention and adherence to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.

Detailed description: Fatigue is highly prevalent in survivors of diffuse-large B-cell lymphoma (DLBCL). Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients (diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods) have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue in this patient population. This fatigue-reducing diet (FRD) was shown to improve fatigue and sleep in breast cancer survivors compared to regular diet. This FRD diet aligns with the standard of care dietary recommendations for cancer survivors promoted by the American Cancer Society (ACS) . The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing. Phone counseling will be weekly for the first month, and then biweekly for the next two months, for a total of 8 phone sessions. Counseling sessions take \~15-30 minutes. Dietary intake will be assessed using an electronic food frequency questionnaire at baseline and 3 months. Fatigue will be assessed using an online survey at baseline and 3 months. The purpose of the study to ascertain the percentage of patients who are able to complete all the study questionnaires and visits and adhere to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18+) with Diffuse large B-cell lymphoma (DLBCL) who have completed their upfront chemoimmunotherapy, and remained in remission for 2 years prior to enrollment

Exclusion Criteria:

* Unable to provide consent or speak English

Primary outcomes:
measure: Feasibility of intervention
timeFrame: 3 months
measure: Adherence to fatigue reduction diet
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tonya Orchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: