Exercise and Diet for Fatigue in Lymphoma

Overseen By Devin McCarthy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Other malignancies, Cognitive impairment, Serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how exercise and diet can reduce fatigue in individuals with certain slow-growing blood cancers, such as chronic lymphocytic leukemia (CLL). Researchers seek to discover if a personalized supportive care program, which includes tailored exercise and dietary guidance, can alleviate fatigue. Individuals diagnosed with these conditions who frequently experience fatigue may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore personalized care strategies that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multidisciplinary intervention program is safe for patients with lymphoma?

Research has shown that exercise and diet programs can be safe and beneficial for people with chronic lymphocytic leukemia (CLL). These programs aim to enhance quality of life and overall health. Studies have found that active individuals often report feeling better and stronger, which makes daily tasks easier to manage.

Additionally, researchers have explored healthy lifestyle changes as a way to help people with CLL maintain better health. No reports of serious side effects have emerged from these programs, suggesting that a personalized plan involving exercise and diet is generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Supportive Care Program for lymphoma-related fatigue because it offers a new approach focused on lifestyle changes rather than medication. Unlike traditional treatments that primarily rely on drugs to manage symptoms, this program emphasizes tailored exercise and diet plans to improve overall well-being. This method could empower patients to take an active role in their health and potentially reduce fatigue more naturally and sustainably.

What evidence suggests that this personalized supportive care program is effective for fatigue in lymphoma?

Research has shown that combining exercise and a healthy diet benefits people with chronic lymphocytic leukemia (CLL). Strength training, in particular, strengthens muscles and increases muscle mass, helping manage common side effects. Studies have found that people with CLL who remain active report a better quality of life, improved physical abilities, and fewer symptoms. This trial will assess a Personalized Supportive Care Program, which includes personalized exercise and diet plans, designed to reduce fatigue and improve well-being for CLL patients. Healthy lifestyle changes, like those in this supportive care program, can help CLL patients maintain better overall health. ^{1 2 3 4 6}

Who Is on the Research Team?

Christopher Jensen, MD MSCR

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with certain slow-growing lymphomas, including CLL/SLL, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom's Macroglobulinemia, and Cutaneous T-Cell Lymphoma. It aims to help those experiencing cancer-related fatigue.

Inclusion Criteria

Subjects willing and able to comply with study procedures based on the judgment of the investigator

I have been diagnosed with a slow-growing type of lymphoma.

Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information

Exclusion Criteria

I have other types of cancer besides the one being treated.

I do not have a serious illness that would stop me from safely doing exercises.

Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a personalized exercise and dietary intervention program, including two patient-clinician consultations for exercise and nutrition.

12 weeks

2 consultations (in-person)

Follow-up

Participants are monitored for changes in fatigue and overall health using PROMIS questionnaires.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Supportive Care Program

Trial Overview The study tests a supportive care program focusing on exercise and diet to combat fatigue in lymphoma patients. It will include 30 subjects with CLL/SLL and 10 subjects with other specified types of indolent lymphomas.

How Is the Trial Designed?

Group I: Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma Experimental Treatment 2 Interventions

Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

CLL Society

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

In a study involving 360 women with early breast cancer undergoing chemotherapy and radiotherapy, an Adapted Physical Activity Diet (APAD) program did not significantly reduce cancer-related fatigue compared to usual care, indicating limited efficacy in this context.

However, the APAD program was associated with a smaller proportion of patients experiencing confirmed depression at the end of follow-up, suggesting potential mental health benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial. Jacot, W., Arnaud, A., Jarlier, M., et al.[2021]

A systematic review of 11 studies with 1530 cancer patients found that supervised physical activity significantly reduces cancer-related fatigue, with a strong effect size (SMD = -1.69).

Both combined aerobic and resistance training, as well as aerobic, resistance, and stretching exercises, were effective in reducing fatigue, suggesting these should be included in cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. Meneses-Echávez, JF., González-Jiménez, E., Ramírez-Vélez, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11931114/

Effects of a strength physical exercise program in chronic ... Specifically, strength training could help manage some of the common adverse effects of CLL. Strengthening muscles and increasing muscle mass ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12248605/

Best Supportive Care for Patients with Chronic Lymphocytic ... This review explores how supportive care strategies such as vaccines, cancer screenings, and healthy lifestyle changes can help people with CLL stay healthier.

3. cancerresearchuk.org cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-diet-and-exercise-for-people-with-chronic-lymphocytic-leukaemia-hiit-cll-study

A study looking at diet and exercise for people with chronic ... This study is looking at whether diet and exercise can improve the health of people with chronic lymphocytic leukaemia (CLL).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jha2.70100

Physical Activity, Symptoms, Quality of Life and Exercise ... This study explored physical activity among people with CLL and assessed differences and relationships in treatment stage, symptoms, quality of ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.02.10.25321744v1.full.pdf

Physical Activity, Symptoms, Quality of Life and Exercise ... Physically active participants reported better QoL (p=0.020), physical functioning (P=0.003) and role functioning (p=0.020) as well as lower ...

6. medrxiv.org medrxiv.org/content/10.1101/2025.02.10.25321744v1.full-text

Physical Activity, Symptoms, Quality of Life and Exercise ... Physically active participants reported better QoL (p=0.020), physical functioning (P=0.003) and role functioning (p=0.020) as well as lower ...