Behavioral interventions to reduce fatigue in chronic lymphocytic leukemia patients
HEALTH4CLL2: A Randomized Waitlist Control Trial of Behavioral Interventions in Patients With Chronic Lymphocytic Leukemia
NA · M.D. Anderson Cancer Center · NCT05879133
This study tests whether a structured diet and exercise program can help reduce fatigue and improve overall health in people with chronic lymphocytic leukemia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05879133 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a structured diet and exercise program aimed at reducing fatigue in patients with chronic lymphocytic leukemia (CLL). Participants will engage in a longitudinal intervention that includes physical activity and dietary modifications, with their progress assessed through various questionnaires and performance tests. The study also aims to explore changes in metabolic and immunologic parameters, as well as the composition of the fecal microbiome, to better understand the impact of these interventions on overall health and quality of life for CLL survivors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with a confirmed diagnosis of chronic lymphocytic leukemia who are currently experiencing low levels of physical activity.
Not a fit: Patients with other active malignancies, significant cognitive impairments, or those who have undergone major surgery recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve fatigue levels and overall quality of life for patients living with chronic lymphocytic leukemia.
How similar studies have performed: Previous studies have shown promising results with similar behavioral interventions in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults age 18-85 years of age with a histologically confirmed diagnosis of CLL and the ability to provide signed informed consent. * Self-reported physical activity will be assessed prior to enrollment and patients with a physical activity level below the level prescribed in our study will be eligible for inclusion. Exclusion Criteria: * Other active malignancy within 1 year of study enrollment (excluding non-melanoma skin cancer) * Richter's transformation, another medical condition which would prevent safe participation in the behavioral intervention * Major surgery within 1 month of enrollment * Non-English speakers * Cognitively impaired adults * Pregnancy.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Alessandra Ferrajoli, MD — M.D. Anderson Cancer Center
- Study coordinator: Alessandra Ferrajoli, MD
- Email: aferrajo@mdanderson.org
- Phone: (713) 792-2063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Lymphocytic Leukemia