None listed
Conditions
Brief summary
The purpose of this study is to assess the feasibility and safety of an exercise program concurrent with immune checkpoint inhibitor (ICI) immunotherapy for people diagnosed with melanoma. Who is it for? You may be eligible for this study if you are a patient aged 18 years or over with a diagnosis of cutaneous melanoma and are scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment. Study details Participants will be randomly allocated to either an exercise intervention, or standard medical care. Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) involving both supervised and unsupervised exercise sessions. Participants randomised to the control group will receive usual medical care and general exercise advice as per the current exercise oncology guidelines. Participants will be asked to complete a variety of questionnaires, undergo fitness testing, and provide blood samples. It is hoped that findings from this study will inform researchers of the effects of exercise concurrent to ICI immunotherapy, following surgery, for patients with melanoma.
Interventions
The EXHIBIT trial is a prospective two-armed randomised controlled trial with an exercise group and a control group.
Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) and follow a step-down approach.
• Phase 1 (0-3 months): two supervised multimodal (aerobic and resistance) exercise sessions an
The EXHIBIT trial is a prospective two-armed randomised controlled trial with an exercise group and a control group. Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) and follow a step-down approach. • Phase 1 (0-3 months): two supervised multimodal (aerobic and resistance) exercise sessions and one unsupervised aerobic exercise session per week. • Phase 2 (4-6 months): one supervised multimodal exercise session and two unsupervised exercise sessions per week, consisting of one aerobic and one multimodal exercise session. • Phase 3 (7-12 months, or until scheduled ICI treatment completion): patients will be encouraged to continue exercising and will be provided with a home-based exercise program, including two multimodal and one aerobic exercise session per week. Patients will also receive a monthly check-in call to discuss their exercise (including modifications and any potential exercise-related adverse events). Supervised exercise sessions will be conducted in small groups by qualified exercise professionals. These sessions will be conducted at community- or hospital-based gyms, however if face-to-face sessions are unachievable, home-based exercise sessions (supervised live remotely via Zoom) may be made available. Participants will be provided with a home-based exercise program for the unsupervised exercise sessions. The supervised sessions will be at a moderate-vigorous intensity and the unsupervised sessions will be at a moderate intensity, assessed with the Borg RPE Scale. Exercise sessions will be scheduled on days where participants are not receiving ICI treatment, and will be encouraged to have sessions separated by at least a day. The specific exercises that will be prescribed will be tailored to each individual by the exercise professional (based on their condition and fitness level at baseline) with ongoing monitoring and will be modified based on their response. Examples of aerobic exercises that may be included are stationary cycling and using an aerobic step. Examples of resistance exercises that may be included are squats and a chest press. Exercise attendance and adherence will be monitored using an exercise training log that will be completed by the exercise professional for supervised exercise sessions and by the participant for unsupervised exercise sessions.
Sponsors
Australian Catholic University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of cutaneous melanoma Scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment Greater than or equal to 18 years of age ECOG performance status less than or equal to 2 Ability and willingness to travel for the study visits and adhere to the exercise intervention Written informed consent.
Exclusion criteria
Stage IV/metastatic disease Received neoadjuvant immunotherapy Received greater than 1 immunotherapy infusion Receiving treatment for another cancer (excluding non-melanoma skin cancer) Currently performing equal to or more than 150 mins of moderate to vigorous intensity intentional physical activity per week Serious active infection; severe neurologic or cardiac impairment according to ACSM criteria Any contraindications for exercise as determined by the treating clinician Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician Pregnant
Outcome results
None listed