Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

EDICT - Exercise inDuced Changes In Colorectal Cancer Tissues (EDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056691
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
The Royal Bournemouth Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Exercise programme Procedure: Muscle biopsy Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Study Start Date : October 2014
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise programme
Exercise programme Muscle biopsies
Procedure: Exercise programme
The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60 seconds, separated by 60 seconds of recovery eliciting 90% maximal heart rate. The 6 sessions are held over a 2 week period.

Procedure: Muscle biopsy
muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage 3 times: before, during and after the exercise programme




Primary Outcome Measures :
  1. Assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and assess the effects of preoperative exercise on the proliferation of colorectal cancer cells [ Time Frame: 1 year ]
    To assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and to assess the effects of preoperative exercise on the proliferation of colorectal cancer cells by measuring the change in the percentage of cells staining positive for Ki67 (a measure of cell proliferation).


Secondary Outcome Measures :
  1. Changes in molecular markers for the effects of exercise and/or diet on AMPK/ mammilian target of rapamycin signalling pathway [ Time Frame: 12 weeks ]
    Measuring changes in molecular markers for the effects of exercise and/or diet on AMPK/mTOR signalling pathway (phosphorylated 4EBP1 (P4EBP1), phosphorylated protein kinase B (PPKB/AKT), and phosphorylated AMPK (PAMPK).

  2. Changes in AKT expression normal colonic tissue [ Time Frame: 12 weeks ]
    Measuring changes in AKT expression normal colonic tissue - Intensity of AKT1/AKT2 staining, or AKT phosphorylation, a marker of insulin receptor signalling in cells.

  3. Assessing Apoptosis index [ Time Frame: 12 weeks ]
    Assessing Apoptosis index - Percentage of tumour cells staining positive for DNA fragmentation, a marker of cells undergoing apoptosis and therefore cell death.

  4. Changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues [ Time Frame: 12 weeks ]
    Measuring changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues (IR, IGF1R, p53 and its transcriptional target p21, ER, progesterone receptor, tumor necrosis factor-alpha converting enzyme and TIMP3).

  5. Assessing gene expression profiles [ Time Frame: 12 weeks ]
    Assessing gene expression profiles focusing on gene associated with insulin resistance.

  6. Assessing the 11 gene signature [ Time Frame: 12 weeks ]
    Assessing the 11 gene signature that help to predict maximal oxygen uptake gain in patients before and after exercise

  7. Blood methylation profiles. [ Time Frame: 12 weeks ]
    Blood methylation profiles.

  8. Cortisol levels [ Time Frame: 12 weeks ]
    Cortisol levels to evaluate levels of biological stress.

  9. Postoperative complications up to 30 days postoperatively [ Time Frame: 30 days post op ]
    Postoperative complications up to 30 days postoperatively

  10. Moderator variables [ Time Frame: 12 weeks ]
    Moderator variables including state of motivational readiness for exercise, weight change, depression and anxiety

  11. Irisin levels [ Time Frame: 12 weeks ]
    Irisin levels before and after exercise



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal cancer confirmed by histology
  • Considered fit for surgery by surgical and anaesthetic team
  • Considered fit for physical activity programme by MDT
  • Age ≥ 18 years
  • BMI ≥ 26 kg/m2
  • Not pregnant
  • Non obstructing cancer
  • Able to provide written informed consent
  • Patients not having neoadjuvant chemotherapy

Exclusion Criteria:

  • Receiving hormone therapy
  • Patients with diabetes
  • Patients currently on either a dietary or exercise programme reflective of the World Cancer Research Fund Guidelines.
  • Cardiac or renal impairment
  • Excessive use of laxatives
  • History of eating disorders
  • Patients with inflammatory bowel disorders/coeliac
  • Strong family history/polyposis (i.e. more than one 1st degree relative <55yrs)
  • Patients with previous or concurrent malignancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056691


Locations
Layout table for location information
United Kingdom
The Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Poole Hospital
Poole, Dorset, United Kingdom, BH15 2JB
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tamas Hickish, FRCP The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Layout table for additonal information
Responsible Party: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT02056691    
Other Study ID Numbers: ed-1
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by The Royal Bournemouth Hospital:
Resectable
non-metastatic
colorectal
carcinoma
cancer
neoplasm
exercise
effects
program
pre-operative
proliferation
diagnosed
surgery
biopsy
muscle
signalling
IGF1
ki67
p53
response
training
biochemical
pathways
glucose
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases