NCT02056691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

February 5, 2014

Last Update Submit

March 9, 2018

Conditions

Colorectal Cancer

Keywords

Resectablenon-metastaticcolorectalcarcinomacancerneoplasmexerciseeffectsprogrampre-operativeproliferationdiagnosedsurgerybiopsymusclesignallingIGF1ki67p53responsetrainingbiochemicalpathwaysglucose

Outcome Measures

Primary Outcomes (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

    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).

    1 year

Secondary Outcomes (11)

  • Changes in molecular markers for the effects of exercise and/or diet on AMPK/ mammilian target of rapamycin signalling pathway

    12 weeks

  • Changes in AKT expression normal colonic tissue

    12 weeks

  • Assessing Apoptosis index

    12 weeks

  • Changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues

    12 weeks

  • Assessing gene expression profiles

    12 weeks

  • +6 more secondary outcomes

Study Arms (1)

Exercise programme

EXPERIMENTAL

Exercise programme Muscle biopsies

Procedure: Exercise programmeProcedure: Muscle biopsy

Interventions

Exercise programmePROCEDURE

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.

Exercise programme
Muscle biopsyPROCEDURE

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

Exercise programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Poole Hospital

Poole, Dorset, BH15 2JB, United Kingdom

Location

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinomaNeoplasmsMotor ActivityDisease

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tamas Hickish, FRCP

    The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 6, 2014

Study Start

October 1, 2014

Primary Completion

September 19, 2017

Study Completion

October 30, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

GB(2)