Fatigue Reduction Diet in Lymphoma Survivors

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327725
• Other study ID #: 2020C0143
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 24, 2021

Study information

• Verified date: April 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• Fatigue Reduction Diet
Participants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adherence to fatigue reduction diet	Determine percentage of patients who adhered to the fatigue reduction diet protocol	3 months