Prospective Randomised Trial of Exercise and / or Antioxidants in COlorectal Cancer Patients Undergoing Surgery.

NCT02264496 | Completed

• 1 other identifier: 13/YH/0322 V3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the mainstay of curative therapy. With the screening program enabling early detection, surgery plays an important role in treatment strategies. Surgery imparts a significant physiological and psychological stress on cancer patients.Recent research has demonstrated that a fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake can improve outcomes by reducing the physiological stress response to surgery. The primary objective of this study is to determine whether a defined exercise programme can improve recovery and reduce complications after surgery.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Exercise; CPEX; Exercise, Physical; Exercise, Aerobic; Surgery

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Post-operative hospital length of stay until medically fit for discharge.

  Up to 3 months

Secondary Outcomes (4)

• Antioxidant capacity

  Up to 4 weeks

• Exercise capacity

  Up to 3 months

• Complications

  Up to 3 months

• Quality of Life Questionnaires

  Up to 3 months

Study Arms (2)

Control

NO INTERVENTION

Standard pre-operative care

Exercise

EXPERIMENTAL

A 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme. '

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with colorectal cancer listed for elective resection surgery who have consented to participate in the study.

You may not qualify if:

• History of unstable angina/unstable coronary artery disease or a heart attack in the previous month
• Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease
• Severe Infections and fever
• Uncontrolled metabolic diseases
• Uncontrolled asthma
• Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
• Resting heart rate of more than 120 BPM
• Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg
• Recent cerebrovascular accident
• Pregnancy
• Preexisting severe physical disability
• Age \<18 years
• Unwilling to allow their GP to be informed of their participation in the study

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Academic Surgical Unit, Castle Hill Hospital

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John Hartley, MD FRCS

  Hull and East Yorkshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 15, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

GB (1)