Clinical trial · Interventional
Effects of Acute and Chronic Exercise on Myeloid-Derived Suppressor Cells in Melanoma Patients
NCT05615883CI-TRIAL-00081597AgilitycompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to investigate the effects of ketogenic milieu induced by acute exercise as well as the effects of recurrent exercise bouts on functional status and the accumulation in peripheral blood of MDSCs and the consequent balance on antitumor immunity in melanoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEP Group Walking Sessions | Other | — | UNRESOLVED |
| CEP Group Walking Sessions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AEP Group
- description
- First series of patients (10 pts) will be assigned to the Acute Exercise Protocol Group (AEP Group). The acute program consists in a single walking session on a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, treadmill speed will be increased until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner) and the walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
- interventionNames
- Other: AEP Group Walking Sessions
- type
- EXPERIMENTAL
- label
- CEP Group
- description
- Second series of patients (10 pts) will be assigned to the Chronic Exercise Protocol Group (CEP Group). The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. The walking intensity will be defined during a treadmill test performedbefore the beginning of the exercise program. Each exercise session will beginwith a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, patients will increase treadmill speed until reaching target HRR zone.Then the treadmill speed will be maintained stable throughout the exercise session. The first training session will be organized in hospital with supervision of research staff. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner) and walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age from 18 to 65 years at the time of recruitment * Histologically confirmed diagnosis of primary melanoma * Patients who are candidate to curative surgery for primary melanoma, skin radicalization or sentinel node biopsy. * American Society of Anaesthesiologists (ASA) status I * Willingness and ability to comply with the protocol, the scheduled visits, treatment plans, laboratory tests and other procedures. * Understanding and signature of the informed consent * Female patients of childbearing potential must agree to sexual abstinence or to use highly effective method of contraception throughout the study (for CEP patients) Exclusion Criteria: * American Society of Anaesthesiologists (ASA) status \> I * Pregnancy or lactation * Known infection from HIV virus * Regular physical exercise (more than 1 exercise workout of moderate to intense exercise activity per week) * Any physical or mental conditions interfering with the ability to perform exercise or to complete the testing procedures.
References
Publications (33)
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