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Exercise to Boost Response to Checkpoint Blockade Immunotherapy
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
Details
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 22 |
| Start date | 2022-06-21 |
| Completion | 2026-08 |
Conditions
- Cutaneous Melanoma
- Cutaneous Squamous Cell Carcinoma
- Merkel Cell Carcinoma
Interventions
- Exercise
- Checkpoint Blockade, Immune
Primary outcomes
- 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