Fatigue Reduction Diet in Lymphoma Survivors

NCT05327725 | Completed

• 1 other identifier: OSU-20182
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Large B-Cell, Diffuse; Fatigue

Keywords

fatigue reduction diet

Outcome Measures

Primary Outcomes (2)

• Feasibility of intervention

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

  3 months

• Adherence to fatigue reduction diet

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

  3 months

Study Arms (1)

Fatigue Reduction Diet Intervention

EXPERIMENTAL

Participants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol via 8 remote phone or video telehealth sessions with a registered dietitian over 3 months.

Other: Fatigue Reduction Diet

Interventions

Fatigue Reduction Diet OTHER

Participants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol.

Fatigue Reduction Diet Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent or speak English

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Fatigue

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonya Orchard, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: March 15, 2021
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: September 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)