Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma
Conditions
Keywords
Exercise, Checkpoint Blockade Immunotherapy, Immunotherapy, Skin Cancer
Brief summary
30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles
Interventions
OTHERExercise
30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Age ≥ 18 years * Able to read and speak English fluently * Capable of giving informed consent * Reported ability to complete 20-30 minutes moderate exercise per positive response to "can you currently walk unaided for six minutes or more?". * Scheduled for first-time checkpoint blockade immunotherapy with FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab in the absence of other therapies (e.g. targeted therapy) * Melanoma patients (adjuvant setting) * Melanoma patients (neoadjuvant setting) * cuSCC patients (neoadjuvant setting) * Merkel cell carcinoma patients (neoadjuvant setting) Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series.
Exclusion criteria
* Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted. * Presence of major postoperative complications for which an exercise intervention may not be warranted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Consenting to Trial | Up to 12 months | Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval |
| Participants Completing Exercise | Up to 12 months | Proportion of participants randomized to the exercise intervention who complete at least 75% of schedule exercise routines; 95% CI will be determined for this proportion. |
| Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting | Up to 12 Months | The length of time without signs or symptoms of cancer |
| Pathological Complete Response (pCR) - Neoadjuvant Setting | Up to 4 Months | The occurrence of pathological complete response in resected tumor tissue. pCR will be determined by absence of tumor cells. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter Kanetsky, PhD, MPH
Moffitt Cancer Center
Outcome results
None listed