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

Trial Summary

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 data supports the effectiveness of the treatment Personalized Supportive Care Program for fatigue in lymphoma?

Research shows that supervised exercise can help reduce cancer-related fatigue, which is a common issue for cancer patients. Although the studies focus on different types of cancer, they suggest that exercise, a component of the Personalized Supportive Care Program, may be beneficial for managing fatigue in lymphoma patients as well. ^{1 2 3 4 5}

Is the Personalized Supportive Care Program, which includes exercise and diet, safe for humans?

Research shows that supervised exercise and dietary programs are generally safe for cancer patients, as they are often used to help manage cancer-related fatigue. These programs have been tested in various cancer types, including breast, prostate, and colorectal cancer, without significant safety concerns. ^{1 2 3 5 6}

How does the Personalized Supportive Care Program treatment for fatigue in lymphoma differ from other treatments?

The Personalized Supportive Care Program is unique because it combines exercise and diet specifically tailored to reduce fatigue in lymphoma patients, focusing on improving both physical and psychological well-being. Unlike standard treatments, this program emphasizes a holistic approach with supervised exercise and nutritional support, which has shown benefits in muscle maintenance and overall fitness without adverse effects. ^{1 2 4 7 8}

What is the purpose of this trial?

This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.

Research Team

Christopher Jensen, MD MSCR

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Does exercise intensity matter for fatigue during (neo-)adjuvant cancer treatment? The Phys-Can randomized clinical trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of supervised exercise on progression-free survival in lymphoma patients: an exploratory follow-up of the HELP Trial. [2018]

5. Switzerland 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A central role for apathy in the effectiveness of interventions for cancer-related fatigue. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Whole-Body Electromyostimulation Combined With Individualized Nutritional Support Improves Body Composition in Patients With Hematological Malignancies - A Pilot Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Physical Exercise Intervention on Psychological and Physical Fitness in Lymphoma Patients. [2020]