The CHALLENGE Trial. A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patient with High Risk Stage II or Stage III Colon Cancer: A Randomised Controlled Trial — ASN Events
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The CHALLENGE Trial. A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patient with High Risk Stage II or Stage III Colon Cancer: A Randomised Controlled Trial (10546)

Haryana Dhillon 1
  1. University of Sydney, Sydney, NSW, Australia

Aims - Our aim is to determine the efficacy of physical activity (PA) in reducing disease recurrence in patients with localised colon cancer. Our primary hypothesis is that a PA program will improve disease-free survival (DFS) in patients with resected stage II and III colon cancer who have completed adjuvant therapy.  In addition, we hypothesise that PA can improve fatigue, quality of life (QOL), physical functioning and body composition.

Methods - A multi-centre phase 3 RCT between Australia and Canada.  Subjects are randomised to a PA program or standard of care.   The primary objective is to compare DFS between patients in PA and control arms. The main secondary objectives are to compare: 1. fatigue, QOL, depression, anxiety, sleep, body composition, PA behaviour and fitness; 2. overall survival (OS); 3. association of cytokines, and insulin axis levels with PA, fatigue, and DFS. 4. Health Economics evaluation of the PA intervention.   The study intervention is a 36-month physical activity programme aiming to achieve > 10 metabolic equivalents/week above baseline compared to usual standard of care.  Study assessments include: Disease status, fitness, PA, body composition, QOL questionnaires at 0/6/12/18/24/30/36 months.  Then annual patient reported outcomes and disease status until study closure. 

Current Status - CHALLENGE recruitment stands at 259 participants registered of whom 224 have been randomised (62 in Australia and 162 in Canada) of a planned 972. Within Australia, there are 24 active sites. Rates of adherence in the intervention group are being closely monitored with the aim of maintaining 95% adherence at the end of phase I and 90% over phases II and III.  Study recruitment will continue and additional participating sites are welcome.