I-Move: A randomised controlled pilot trial of a personalised, semi-supervised exercise intervention to reduce fatigue for patients receiving immunotherapy for stage IV Melanoma

Not Applicable

• Conditions: Melanoma; Immunotherapy; Fatigue; Cancer - Malignant melanoma; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12619000952145
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-08
• Study Completion: 2020-01-17
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

•Aged 18 years or older
•Diagnosis of stage IV Melanoma
•Scheduled to commence receiving single agent Ipilimumab, Nivolumab or Pembrolizumab; or combination Ipilimumab and Nivolumab immunotherapy, and have not yet had their second infusion
•Able to speak and read English
•Deemed suitable to take part in an exercise intervention by their treating clinician
•Access to a smartphone

Exclusion Criteria

Screening:
•ECOG performance >2
Physical/Safety Assessment:
•Peripheral Neuropathy: An assigned WHO Grade of 3 or above will preclude participation in the trial.
•Contra-indications to exercise testing including the following
oMyocardial infarction or unstable angina in last 3 months
oCerebrovascular event or transient ischemic attack in last 3 months
oPulmonary embolic event within 3 months, existing acute or chronic deep vein thrombosis
oPresentation with active sepsis

Study & Design

• Study Type: Interventional
• Study Design: Not specified