Colorectal Cancer Clinical Trial
Official title:
Clinical and Biological Effects of a Preoperative Exercise Programme in Colorectal Tumour and Skeletal Muscle Tissues (Exercise inDuced Changes In Colorectal Cancer Tissues)
This pilot study looks to explore the biological effects of exercise on cancer and muscle cells using a two week exercise program (HIThigh intensity training) on 20 patients with newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery. Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the feasibility of recruiting participants to and carrying out a two week preoperative exercise program in patients with colorectal cancer.
Patients undergoing investigation for symptoms of colorectal cancer presenting to the
hospital will undergo standard diagnostic procedures. Once resectable nonmetastatic cancer
has been diagnosed (i.e. cancer that has not spread beyond the bowel), is amenable to
surgical resection as decided by the colorectal multidisciplinary and if the patient fulfills
the selection criteria, they will be asked if they wish to participate in the study. They
will be given information regarding the study at the time of diagnosis. If they give their
consent then a formal consenting process will take place at the next routine appointment.
During this appointment the patient will have the opportunity to ask questions. A member of
the study team will explain the study in detail, answer any questions potential participants
(and their partners/ carers) have. The patient is free to refuse participation or withdraw
from the study at any time without this affecting their care, this is explained in the
information and will be discussed further at the time of informed consent. If the patient
agrees to participate in the trial, following the provision of informed consent and before
embarking on the exercise programme they will need to fill in two questionnaires, the
International Physical Activity Questionnaire (Long) and Dietary Intervention in Primary Care
Questionnaire (DINE). They will be counseled to try and maintain their normal exercise level
and their calorie intake. Blood samples will also be taken, analyzed and stored for further
analysis including possible genetic analysis at a later stage before starting the exercise
regime. They will have a muscle biopsy under local anaesthetic taken from the thigh, again
for analysis and storage.
Participants will undergo an initial assessment of their baseline exercise ability and oxygen
absorption using an upright exercise bike with concurrent ECG readings and breath analysis.
The two week preoperative exercise regime will be planned depending on the patient's
operation date. The exercise regime consists of 10 sessions of exercise against a constant
load, each lasting 60s, separated by 60s of recovery eliciting 90% maximal heart rate.
The 6 sessions are held over a 2 week period. Each patients exercise ability and oxygen
absorption will be remeasured at the end of the 2 week period and a second sample of blood
taken for comparison. During the operation a sample of adipose tissue near the tumour site
will be taken separately to the main sample. A muscle biopsy from the thigh will also be
taken at the same time. As a standard of clinical care all patients are reviewed in the
outpatient setting 6 weeks postoperatively. When patients attend this follow up appointment a
final blood test and muscle biopsy (under local anaesthetic) will be taken to assess the
longer term effects of the exercise program. Patient consent will be sought for this
separately although it will be discussed at the initial introduction to the study.
Patients are free to withdraw from the study at any time and if there are any adverse events
or concerns regarding the continuation of the study for a patient then they will be
withdrawn.
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