Personalized exercise and nutrition program to reduce cancer-related fatigue
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
This program will try a personalized exercise and diet plan to reduce fatigue for adults with indolent lymphomas (including CLL/SLL and follicular lymphoma).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06860880 on ClinicalTrials.gov |
What this trial studies
Participants receive individualized exercise prescriptions combining aerobic and resistance training based on medical history and current activity, plus tailored nutrition counseling from an oncology dietitian. Each participant completes two clinician consultations (one for exercise, one for nutrition) and submits weekly exercise journals and numeric dietary adherence ratings (0-10). The protocol enrolls about 30 people with CLL/SLL and 10 with other indolent lymphoma subtypes to test feasibility and adherence of the multidisciplinary approach. Outcomes focus on fatigue symptom changes and adherence to prescribed exercise and diet regimens.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed diagnosis of indolent lymphoma (including CLL/SLL, FL, MZL, LPL, Waldenström's, or CTCL) who report significant fatigue (PROMIS Fatigue >50), can consent, and are judged able to follow the exercise and nutrition plans.
Not a fit: Patients with other active malignancies, significant cognitive impairment, or unstable/serious illnesses that make exercise unsafe are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could lessen fatigue and improve daily function and quality of life for people with indolent lymphomas.
How similar studies have performed: Exercise and dietary interventions have previously shown benefits for cancer-related fatigue in other cancer populations, though tailored programs specifically for indolent lymphomas are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria: * Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. * Subjects are willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at the time of consent. * Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma. * Significant symptoms of fatigue, as defined by PROMIS Fatigue score \>50. Exclusion Criteria: * Other co-existing malignancies. * Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions. * Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia/thrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician. * 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
Where this trial is running
Chapel Hill, North Carolina
- North Carolina Basnight Cancer Hospital — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Jensen, MD MSCR — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Devin McCarthy
- Email: devin_mccarthy@med.unc.edu
- Phone: (919)-445-4852
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.