PEACH Trial: Prescribed Exercise After Chemotherapy

NCT01030887 | Completed Phase 3 DMC

• 1 other identifier: CTPF/2008/12
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer; Exercise; Physical Activity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Modified Bruce Treadmill Test (Fitness)

  0, 8 weeks, 3 months

Secondary Outcomes (5)

• FACT-G scale (Quality of life-overall)

  0, 8 weeks, 3 months

• FACT-F (Fatigue)

  0, 8 weeks, 3 months

• RT3 Accelerometry (Activity level)

  0, 8 weeks, 3 months

• Tanita Body Fat Assessment (% fat)

  0, 8 weeks, 3 months

• SF-36v2 (Quality of life-functional aspects)

  0, 8 weeks and 3 months

Study Arms (2)

Exercise Programme

ACTIVE COMPARATOR

This will consist of an 8-week exercise programme, performed twice per week.

Behavioral: Exercise programme

Usual Care

PLACEBO COMPARATOR

Standard practice including opportunistic exercise advice and patients' self-directed physical activity

Behavioral: Exercise programme

Interventions

Exercise programme BEHAVIORAL

Moderate intensity exercise

Exercise Programme; Usual Care

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

Medical Oncology Department, St. James's Hospital

Dublin, 8, Ireland

Location

Related Publications (1)

• Walsh JM, Hussey J, Guinan E, O' Donnell D. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': a feasibility study PEACH trial: prescribed exercise after chemotherapy. BMC Cancer. 2010 Feb 15;10:42. doi: 10.1186/1471-2407-10-42.

  PMID: 20156345 BACKGROUND

Related Links

• Sponsor's web page
• University affiliated to this research
• Hospital affiliated to this research

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• 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

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 15, 2011

Record last verified: 2009-11

Locations

IE (1)