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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.


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced Rectal Cancer

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Trial Information

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.


Inclusion Criteria:



- diagnosis of T3N+ rectal cancer

- above age of 18

- able to conduct a cardiopulmonary exercise test on a cycle ergometer

Exclusion Criteria:

- unable to conduct a cardiopulmonary exercise test on a cycle ergometer

- metastatic disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery.

Outcome Time Frame:

Between baseline and week 0 and between week 0 at week 6 post-NACRT

Safety Issue:

No

Authority:

United Kingdom: Research Ethics Committee

Study ID:

11/H1002/12c

NCT ID:

NCT01859442

Start Date:

January 2012

Completion Date:

November 2013

Related Keywords:

  • Locally Advanced Rectal Cancer
  • Rectal Neoplasms

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