PEACH Trial: Prescribed Exercise After Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by:
University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT01030887
First received: December 11, 2009
Last updated: August 12, 2011
Last verified: November 2009
  Purpose

Many cancer survivors suffer symptoms such as fatigue and dyspnea which may persist for years or months after their chemotherapy has finished. Despite the known benefits of exercise and its potential to address many of the symptoms after cancer, the type of practical exercise programme which best suits this population is not known.

Many exercise programmes performed in cancer survivors take place over many weeks or months and include people with specific types of cancer. Such programmes may therefore not be suitable for the majority of cancer survivors and would pose serious practical difficulties with high drop-out rates and expensive resource consumption if they were extended into clinical practice.

We propose to run an 8-week exercise intervention in a mixed cancer population.

Hypothesis: A brief, individually tailored 8-week intervention will increase fitness and improve other physical symptoms in a mixed cancer survivor population after chemotherapy.


Condition Intervention Phase
Cancer
Behavioral: Exercise programme
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:
  • Modified Bruce Treadmill Test (Fitness) [ Time Frame: 0, 8 weeks, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FACT-G scale (Quality of life-overall) [ Time Frame: 0, 8 weeks, 3 months ] [ Designated as safety issue: No ]
  • FACT-F (Fatigue) [ Time Frame: 0, 8 weeks, 3 months ] [ Designated as safety issue: No ]
  • RT3 Accelerometry (Activity level) [ Time Frame: 0, 8 weeks, 3 months ] [ Designated as safety issue: No ]
  • Tanita Body Fat Assessment (% fat) [ Time Frame: 0, 8 weeks, 3 months ] [ Designated as safety issue: No ]
  • SF-36v2 (Quality of life-functional aspects) [ Time Frame: 0, 8 weeks and 3 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Programme
This will consist of an 8-week exercise programme, performed twice per week.
Behavioral: Exercise programme
Moderate intensity exercise
Placebo Comparator: Usual Care
Standard practice including opportunistic exercise advice and patients' self-directed physical activity
Behavioral: Exercise programme
Moderate intensity exercise

Detailed Description:

Background: Many cancer survivors suffer a range of physical and psychological symptoms with may persist for years or months after treatment finishes. Despite the known benefits of exercise and its potential to address many of these adverse effects of treatment, the role of exercise as well as its optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long, have tight eligibility criteria and are not likely to be practical in the majority of cancer survivors. We plan to investigate a novel brief 8-week intervention which aims to increase physical fitness, and address other physical symptoms in a heterogeneous cancer survivor population.

Methods/design: Approximately 60 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored, supervised, moderate intensity aerobic exercise sessions per week for 8 weeks. All participants will be assessed at baseline (0 weeks), post intervention (8 weeks), and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program.

Discussion: This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additional process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population after chemotherapy treatment with curative intent.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of solid tumour and completion of adjuvant chemotherapy (and/or radiotherapy) with curative intent within the preceding 2-6 months. (Patients who have received neoadjuvant chemotherapy or chemoradiotherapy followed by surgery will also be eligible. In addition, patients continuing onto adjuvant hormone therapy and anti-Her2 directed therapy are eligible).
  • Ability to understand English
  • Willing to be randomised
  • Medical clearance to exercise
  • Age 21-69
  • Fitness level average, fair or poor according to certain pre-determined cut-off points for age and gender(Fletcher et al., 2001)
  • Willing and able to attend supervised exercise sessions twice weekly for a period of 8 weeks, with an intention of achieving > 90% attendance
  • LVEF > 50% and not < 20% worse than baseline in applicable patients

Exclusion Criteria:

  • Evidence of active cancer
  • Chronic medical and orthopaedic conditions that would preclude exercise (eg uncontrolled congestive heart failure or angina, recent MI, breathing difficulties requiring oxygen use or hospitalization)
  • On beta-blocker medication
  • Prior history of another cancer in previous 5 years (exception: non-melanoma skin cancer and non-invasive cancer of the cervix)
  • Confirmed pregnancy
  • Dementia or psychiatric illness that would preclude ability to participate in study
  • Incomplete haematological recovery after chemotherapy (WCC< 3, Hb < 10 or Platelets < 100)
  • BMI > 35
  • LVEF post chemotherapy < 50% or > 20% deterioration of baseline pre-systemic treatment. LVEF criteria are applicable in patients who have received chemotherapy deemed in normal clinical practice to have a potential effect LVEF and in whom the LVEF will have been measured before systemic treatment and at end of chemotherapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01030887

Locations
Ireland
Medical Oncology Department, St. James's Hospital
Dublin, Ireland, 8
Sponsors and Collaborators
University of Dublin, Trinity College
Health Research Board, Ireland
Investigators
Principal Investigator: Dearbhaile O' Donnell, MD St. James's Hospital, Dublin, Ireland
Principal Investigator: Juliette Hussey, PhD Trinity College Dublin, Ireland
Principal Investigator: Julie M Walsh, MSc Trinity College Dublin
  More Information

Additional Information:
Publications:
Responsible Party: Julie Walsh, Trinity College Dublin
ClinicalTrials.gov Identifier: NCT01030887     History of Changes
Other Study ID Numbers: CTPF/2008/12
Study First Received: December 11, 2009
Last Updated: August 12, 2011
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by University of Dublin, Trinity College:
Cancer
Exercise
Physical Activity
Randomized controlled trial

ClinicalTrials.gov processed this record on September 16, 2014