University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany
Location status: Recruiting
NCT Number: NCT07564570
The aim of this research project is to determine whether a short bout of physical exercise immediately before the start of immunotherapy (Nivolumab and Ipilimumab) is feasible and has a positive effect on the effectiveness of immunotherapy. It is known that short-term physical exercise leads to marked changes in the innate and adaptive immune system. These changes-specifically an increase in natural killer (NK) cells and cytotoxic T cells-are associated with a better response to immunotherapy.
The patient population selected for this study consists of patients with advanced-stage melanoma who are receiving Nivolumab and Ipilimumab.
First, we aim to assess whether such an intervention is feasible in a large proportion of patients, as many patients experience disease-related and treatment-related side effects.
Secondary objectives are to demonstrate that the exercise intervention positively influences the immune system and that this, in turn, leads to an improved response to therapy, thereby positively affecting patient survival, improving quality of life, and reducing treatment-related side effects.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Moderate physical activity for 30 minutes on a cycle ergometer
Time frame: 9 weeks
Rate of >70%
Time frame: Time from randomization to progression or death from any cause, up to 30 months.
Median time is reported
Time frame: Difference calculated between blood draw directly before and directly after sport intervention.
Time frame: Time from randomization to progression or death from any cause, up to 30 months.
Median OS is reported.
Time frame: Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
Absolute concentrations
Time frame: Occurrence of side effects during active therapy with nivolumab and ipilimumab; the rate per patient is calculated from randomization to the end of the trial. Up to 30 months.
Amount of patients and fraction experiencing AE and grade according to CTCAE v4.0 is reported.
Contact information is provided by the study sponsor or research team.
Joseph Tintelnot, MD
CONTACT
Julian Kött, MD
CONTACT
Universitätsklinikum Hamburg-Eppendorf
Other
SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma
Acronym: SPRINT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06066138
Adenocarcinoma, Bronchial Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT05136196
Carcinoma, Carcinoma, Squamous Cell
Phoenix, Arizona, United States
View Trial DetailsNCT05155033
Adenocarcinoma, Advanced Locoregional Melanoma
Bethesda, Maryland, United States
View Trial DetailsNCT07281924
Liver Metastases, Melanoma
Madison, Wisconsin, United States
View Trial Details