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Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial

Phase 3
21 Years
70 Years
Not Enrolling

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Trial Information

Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial

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.

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 <

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Modified Bruce Treadmill Test (Fitness)

Outcome Time Frame:

0, 8 weeks, 3 months

Safety Issue:


Principal Investigator

Dearbhaile O' Donnell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. James's Hospital, Dublin, Ireland


Ireland: Medical Ethics Research Committee

Study ID:




Start Date:

January 2010

Completion Date:

August 2011

Related Keywords:

  • Cancer
  • Cancer
  • Exercise
  • Physical Activity
  • Randomized controlled trial