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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise and weight management can reduce fatigue in chronic lymphocytic leukemia (CLL) survivors. Participants will join different groups; some will start the program immediately, while others will wait. All participants will receive tools such as a Fitbit for tracking activity, resistance bands for exercise, and educational materials. This trial suits CLL survivors who frequently feel tired and are not yet very active. As an unphased trial, it offers participants a unique opportunity to contribute to research that could enhance the quality of life for 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 prior data suggests that these behavioral interventions are safe for CLL survivors?

Research has shown that exercise and weight management are generally safe for people with chronic lymphocytic leukemia (CLL). Studies have found that exercise can improve bone strength and balance, common concerns for those with CLL. One study found that exercise programs can enhance quality of life, boost mental health, and reduce frailty in CLL patients. This indicates that exercise is usually safe and rarely causes harm.

No specific reports of serious problems from these activities exist for CLL patients. Previous research has confirmed that exercise is safe and acceptable for CLL patients, especially those not yet receiving cancer treatment. Overall, this evidence suggests that exercise and weight management are safe and may benefit people living with CLL. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral interventions for chronic lymphocytic leukemia (CLL) because they focus on exercise and weight management, which are not typical approaches for this condition. Unlike standard treatments for CLL, which often involve chemotherapy or targeted therapies, these interventions use tools like Fitbits and resistance bands to encourage a healthier lifestyle. This approach not only aims to improve physical health but may also enhance overall well-being, potentially offering a non-invasive complement to traditional medical treatments. By exploring how lifestyle changes can impact CLL, this trial could open new avenues for holistic patient care.

What evidence suggests that exercise and weight management could be effective for improving fatigue in CLL survivors?

This trial will evaluate the impact of exercise and weight management on individuals with chronic lymphocytic leukemia (CLL). Research has shown that exercise and weight management can benefit people with CLL. Studies have found that active individuals tend to enjoy a better quality of life, perform daily tasks more easily, and experience less fatigue. One study found that strength training can alleviate common CLL side effects by increasing muscle strength and size. Another study suggested that moderate to high-intensity exercise can enhance physical ability and heart health, potentially reducing fatigue. Overall, staying active positively impacts how CLL survivors feel and function. ^{1 5 6 7 8}

Who Is on the Research Team?

Alessandra Ferrajoli, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

I have not had major surgery in the last month.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02764-9

High-intensity interval training and strength conditioning in ... This systematic review explores the impact of physical exercise on chronic lymphocytic leukemia (CLL) patients' physical fitness, immunologic, and quality of ...

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

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 ...

4. 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 ...

5. nature.com nature.com/articles/s41598-021-02352-6

A pilot study of high-intensity interval training in older ... Twelve weeks of moderate-intensity aerobic training improved physical function, fatigue, cardiovascular fitness, and QOL, while 36-weeks of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06654206

Effects of a Strength Physical Exercise Program in Chronic ... Effects of a strength physical exercise program in chronic lymphocytic leukemia patients on quality of life, mental health, and frailty: a randomized ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12100989/

High-intensity interval training and strength conditioning in ... This systematic review explores the impact of physical exercise on chronic lymphocytic leukemia (CLL) patients' physical fitness, immunologic, and quality of ...

8. isrctn.com isrctn.com/ISRCTN55166064

Safety and acceptability of exercise for chronic lymphocytic ... This study aims to overcome these problems by investigating the effects of exercise in people with chronic lymphocytic leukaemia (CLL) on a 'watch-and-wait' ...