The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness

This study has been completed.
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
Michelle Mossa, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01859442
First received: May 13, 2013
Last updated: May 5, 2014
Last verified: September 2013
  Purpose

The present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery.

Twelve patients will be randomised (1:1) to an intervention and a control group. The patients randomized to the intervention group will attend a total of 18 tailored exercise sessions (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment. Where possible the exercise training sessions will be arranged to fit in with other appointments at the hospital. Patients randomized to the control group will be unsupervised. They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2 Kinetics test will be performed. Patients will also be invited to attend 3 health related quality of life interviews at week 0, 3 and 6 during their exercise programme. These appointments will be directly before or after their exercise sessions to minimise hospital attendence.

Following surgery only routine clinically relevant observational data will be collected. These data will relate to hospital length of stay, the level of care required following surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this information can be accessed from patient notes and on the electronic patient records system.

This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic Resonance Spectroscopy (31P MRS) scans and the blood samples.

HYPOTHESIS

  1. Interval exercise training will maintain or improve fitness (measured by anaerobic threshold) in patients undergoing neoadjuvant chemoradiotherapy.
  2. Interval exercise training is safe and feasible in patients undergoing neoadjuvant chemoradiotherapy awaiting rectal cancer resection.
  3. Interval exercise training will improve other measures of physical fitness measured in the CPET and the oxygen uptake kinetics test.
  4. Interval exercise training will improve quality of life in patients undergoing neoadjuvant chemoradiotherapy.
  5. Improvements in physical fitness will reduce postoperative complications following major rectal cancer surgery.
  6. Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise training program?
  7. Can we find an optimal time for surgery when fitness and cancer downstaging are at their best?

HYPOTHESIS for Mechanism Pilot Study

  1. To explore the exponential rate constant of post-exercise phosphocreatine recovery.
  2. To explore the alteration in cellular and mitochondrial energetics eg. Change in mitochondrial numbers, change in mitochondrial activity and respiration.

Condition Intervention Phase
Locally Advanced Rectal Cancer
Procedure: Structured responsive interval exercise training programme
Other: Sham group
Phase 0

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

Resource links provided by NLM:


Further study details as provided by Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery. [ Time Frame: Between baseline and week 0 and between week 0 at week 6 post-NACRT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alterations in mitochondrial energetics post-chemoradiotherapy and exercise [ Time Frame: Between baseline and week 0 and between week 0 and week 6 post-NACRT ] [ Designated as safety issue: No ]
    Changes in 31- Phosphoromagnetic resonance spectroscopic (31-PMRS) ATP:ADP ratio


Enrollment: 12
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise group
6 week structured responsive interval exercise training programme
Procedure: Structured responsive interval exercise training programme
Sham Comparator: Control group
Negative, unsupervised, out of hospital control group
Other: Sham group
NO intervention in this group, only standard care (no exercise programme)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01859442

Locations
United Kingdom
Aintree University Teaching Hospitals NHS FT
Liverpool, Merseyside, United Kingdom, L97Al
Sponsors and Collaborators
Michelle Mossa
University of Liverpool
  More Information

No publications provided

Responsible Party: Michelle Mossa, Research an Developement Deputy Director, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01859442     History of Changes
Other Study ID Numbers: 11/H1002/12c
Study First Received: May 13, 2013
Last Updated: May 5, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014