Phase 1 Study of Mitochondrial Energetics After Long Course Chemoradiotherapy and a Short Term Exercise Programme in Locally Advanced Rectal Cancer Patients - A Randomized Controlled Trial.
All patients will attend 5 sets of appointments at the hospital for diagnostic tests and 3
appointments at the University of Liverpool Magnetic Resonance and Image Analysis Research
Centre (MARIARC). Three appointments will be prior to chemoradiotherapy treatment, and the
other 4 will be after chemoradiotherapy. Two of these 5 appointments are part of routine
care. The first 4 appointments will last about an hour. Patients will complete 3 quality of
life questionnaires on recruitment, during chemotherapy, before and 4-6 weeks after surgery.
These 3 questionnaires will take 20 minutes to fill in. The fourth and fifth appointments
will consist of Computed Tomogram (CT) and Magnetic Resonance Imaging (MRI) scans in our
radiology department to assess cancer staging. These appointments will last about 1 hour 30
minutes.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery.
Between baseline and week 0 and between week 0 at week 6 post-NACRT
No
United Kingdom: Research Ethics Committee
11/H1002/12c
NCT01859442
January 2012
November 2013
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