Skip to main content
Clinical Trials/NCT05327725
NCT05327725
Completed
Not Applicable

Fatigue Reduction Diet in Survivors of Diffuse Large B-Cell Lymphomas; A Preliminary Study

Ohio State University0 sites10 target enrollmentMarch 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphoma, Large B-Cell, Diffuse
Sponsor
Ohio State University
Enrollment
10
Primary Endpoint
Adherence to fatigue reduction diet
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
September 24, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tonya Orchard

Associate Professor

Ohio State University

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

Outcomes

Primary Outcomes

Adherence to fatigue reduction diet

Time Frame: 3 months

Determine percentage of patients who adhered to the fatigue reduction diet protocol

Feasibility of intervention

Time Frame: 3 months

Determine feasibility of recruiting, enrolling and retaining participants in the study, represented as percentage of patients who completed the study.

Similar Trials