Behavioral Interventions for Chronic Lymphocytic Leukemia

Overseen By Alessandra Ferrajoli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Other malignancy, Major surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

30 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if exercise and weight management can help to improve feelings of fatigue in CLL survivors.

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 focuses on exercise and weight management for CLL survivors.

What data supports the effectiveness of the treatment Exercise and Weight Management for Chronic Lymphocytic Leukemia?

Research shows that exercise can improve physical function and quality of life in people with blood cancers like chronic lymphocytic leukemia. Exercise programs, including high-intensity interval training, have been found to reduce fatigue and improve overall well-being in these patients. ^{1 2 3 4 5}

Is exercise safe for people with chronic lymphocytic leukemia?

Exercise, including high-intensity interval training and resistance training, is generally safe and feasible for individuals with chronic diseases like chronic lymphocytic leukemia. It may help reduce cancer-related fatigue and improve quality of life. ^{1 5 6 7 8}

How does the Exercise and Weight Management treatment for Chronic Lymphocytic Leukemia differ from other treatments?

This treatment is unique because it focuses on improving physical function and body composition through exercise and weight management, rather than using medication. It aims to enhance overall health and quality of life for patients with Chronic Lymphocytic Leukemia by incorporating physical activity and nutrition, which is different from traditional drug-based therapies. ^{1 2 7 9 10}

Research Team

Alessandra Ferrajoli, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults aged 18-85 with Chronic Lymphocytic Leukemia (CLL) who feel tired and aren't very active. They must be able to give consent. People won't qualify if they're already as active as the study requires.

Inclusion Criteria

I am less active than the study requires.

I am between 18-85 years old with confirmed CLL and can consent to treatment.

Exclusion Criteria

I have not had any cancer other than non-melanoma skin cancer in the past year.

Richter's transformation or another medical condition which would prevent safe participation in the behavioral intervention

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a diet and exercise training program using a Fitbit and resistance bands, with educational materials provided

1 year

Regular virtual check-ins and in-person visits as needed

Follow-up

Participants are monitored for changes in fatigue, physical activity, dietary behavior, and other health metrics

4 weeks

Treatment Details

Interventions

• Exercise and Weight Management
• Fit Bit
• Questionnaires

Trial Overview The trial tests whether using a Fitbit activity tracker and following weight management plans can reduce fatigue in CLL survivors. Participants will be randomly assigned to start these interventions immediately or after a waiting period.

Participant Groups

Group I: Group 2 (Waitlist) Experimental Treatment 2 Interventions

Participants are randomly assigned a study group, pariticipants will be given the following: * A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale. * Resistance bands with an instructional video on how to use them. * Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.

Group II: Group 1 (Behavioral) Experimental Treatment 2 Interventions

Participants are randomly assigned a study group, pariticipants will be given the following: * A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale. * Resistance bands with an instructional video on how to use them. * Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

CLL Global Research Foundation

Collaborator

Trials

2

Recruited

380+

Findings from Research

A 16-week physical activity intervention significantly improved leisure-time physical activity and reduced fatigue in patients with chronic lymphocytic leukemia (CLL), indicating potential benefits for quality of life.

The intervention was associated with favorable changes in T-cell phenotypes, including an increased CD4:CD8 T-cell ratio and a decrease in T-cell subsets linked to poor outcomes, suggesting a positive impact on immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. Crane, JC., Gordon, MJ., Basen-Engquist, K., et al.[2023]

Participants with acute leukemia reported significant physical and psychological benefits from an inpatient exercise intervention during chemotherapy, with no adverse events noted, indicating that exercise can be safely integrated into treatment.

Despite common barriers like anxiety and physical discomfort, the exercise program was well-received, suggesting that structured exercise can enhance recovery and quality of life for patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Benefits and Barriers to Exercise for Recently Treated Adults With Acute Leukemia Leak Bryant, A., Walton, AL., Pergolotti, M., et al.[2019]

A systematic review of 12 studies with 812 participants found that structured exercise rehabilitation significantly improves physical function in adults undergoing treatment for hematological malignancies, with a moderate effect size (SMD = 0.39).

Multimodal exercise interventions that include both aerobic and resistance training, especially at moderate to vigorous intensities, are particularly effective in enhancing physical function during active treatment for leukemia or lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Rehabilitation on Physical Function in Adults With Hematological Cancer Receiving Active Treatment: A Systematic Review and Meta-Analysis. Moore, M., Northey, JM., Crispin, P., et al.[2023]

A systematic review of 15 studies found that exercise interventions significantly improved physical fitness in adults with hematological malignancies, as measured by the 6-minute walk test and peak oxygen consumption.

While exercise did not show significant effects on grip strength, fatigue, or overall quality of life when comparing groups, within-group analysis indicated that combination exercise improved quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions for physical fitness, fatigue, and quality of life in adult hematologic malignancy patients without receiving hematopoietic stem cell transplantation: a systematic review and meta-analysis. Xu, W., Yang, L., Wang, Y., et al.[2022]

A 12-week program of high-intensity interval training (HIIT) combined with resistance training (RT) significantly improved functional well-being and overall health-related quality of life in adults with chronic lymphocytic leukemia (CLL), as shown by a large effect size (Cohen's d = 1.38).

Participants in the HIIT+RT group experienced meaningful improvements in multiple quality of life measures, while the control group showed limited changes, highlighting the potential benefits of exercise interventions for individuals with CLL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study. Artese, AL., Sitlinger, A., MacDonald, G., et al.[2023]

Exercise interventions during and after chemotherapy for patients with hematological cancer are generally reported as safe and feasible, based on a systematic review of 12 studies, including six randomized controlled trials.

Despite the positive claims about safety and feasibility, many studies lack detailed information on how these conclusions were reached, highlighting the need for more comprehensive reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. Großek, A., Großek, K., Bloch, W.[2023]

In a review of 24 adult studies, strong evidence indicates that exercise interventions significantly improve body composition in hematological cancer survivors, while there is promising but weaker evidence for benefits in cardiorespiratory fitness, fatigue, muscle strength, physical functioning, and quality of life.

For pediatric survivors, 13 studies showed strong evidence that exercise, especially in hospital settings, enhances muscle strength and cardiorespiratory fitness, with no exercise-related risks identified for either adults or children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in adult and pediatric hematological cancer survivors: an intervention review. Wolin, KY., Ruiz, JR., Tuchman, H., et al.[2013]

A pilot study involving 17 children aged 5 to 10 years with acute lymphoblastic leukemia showed that a 6-month home-based exercise intervention was feasible, with 71% of participants completing the program.

The exercise intervention led to significant improvements in physical abilities, including strength and flexibility, with 67% of participants showing enhanced knee strength and 83% improving ankle flexibility, indicating potential benefits for children undergoing cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. Esbenshade, AJ., Friedman, DL., Smith, WA., et al.[2022]

In a study of 60 lymphoma patients participating in a 12-week exercise program, adherence to the exercise regimen was high at 77.8%.

Younger patients (under 40), those with a history of insufficient physical activity, previous radiation treatment, higher body mass index, and smokers showed poorer adherence, highlighting key factors that could inform targeted interventions to improve exercise participation in lymphoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adherence to supervised exercise in lymphoma patients participating in a randomized controlled trial. Courneya, KS., Stevinson, C., McNeely, ML., et al.[2018]

An 80-year-old patient with chronic lymphatic leukemia (CLL) associated with del(11q) showed significant improvement after treatment with ibrutinib, combined with proper nutrition and a structured physical activity program.

The patient's clinical condition normalized over time, with a notable reduction in lymphadenopathy and the absence of del(11q) in follow-up tests, highlighting the effectiveness of a comprehensive treatment approach for elderly patients with CLL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Anecdotal Case Report of Chronic Lymphatic Leukemia with del(11q) Treated with Ibrutinib: Artificial Nourishment and Physical Activity Program. Sica, A., Sagnelli, C., Papa, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. [2023]

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

Perceived Benefits and Barriers to Exercise for Recently Treated Adults With Acute Leukemia [2019]

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

Effects of Exercise Rehabilitation on Physical Function in Adults With Hematological Cancer Receiving Active Treatment: A Systematic Review and Meta-Analysis. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions for physical fitness, fatigue, and quality of life in adult hematologic malignancy patients without receiving hematopoietic stem cell transplantation: a systematic review and meta-analysis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Exercise in adult and pediatric hematological cancer survivors: an intervention review. [2013]

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

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Predictors of adherence to supervised exercise in lymphoma patients participating in a randomized controlled trial. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

An Anecdotal Case Report of Chronic Lymphatic Leukemia with del(11q) Treated with Ibrutinib: Artificial Nourishment and Physical Activity Program. [2021]