CancerPhase 3PEACHNCT01030887
PEACH Trial: Prescribed Exercise After Chemotherapy
A Phase 3 study testing Exercise programme in people with Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2010to Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Exercise programme
- Keywords
- Cancer, Exercise, Physical Activity, Randomized controlled trial
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeBehavioural
Moderate intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise Programme | Active comparator | This will consist of an 8-week exercise programme, performed twice per week. Receives: Behavioral: Exercise programme |
| Usual Care | Placebo comparator | Standard practice including opportunistic exercise advice and patients' self-directed physical activity Receives: Behavioral: Exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Bruce Treadmill Test (Fitness)
Measured: 0, 8 weeks, 3 months
Secondary outcomes (5)
FACT-G scale (Quality of life-overall)
Measured: 0, 8 weeks, 3 months
FACT-F (Fatigue)
Measured: 0, 8 weeks, 3 months
RT3 Accelerometry (Activity level)
Measured: 0, 8 weeks, 3 months
Tanita Body Fat Assessment (% fat)
Measured: 0, 8 weeks, 3 months
SF-36v2 (Quality of life-functional aspects)
Measured: 0, 8 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Investigators
- Dearbhaile O' Donnell, MD, Principal investigator, St. James's Hospital, Dublin, IrelandJuliette Hussey, PhD, Principal investigator, Trinity College Dublin, IrelandJulie M Walsh, MSc, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030887
- Sponsor's protocol ID
- CTPF/2008/12
- Acronym
- PEACH
- Status last verified
- Nov 2009
- First submitted
- 11 Dec 2009
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20156345
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01030887
- Acronym / sponsor ID
- PEACH / CTPF/2008/12
- Conditions
- Cancer
- Keywords
- Cancer, Exercise, Physical Activity, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Programme | Active comparator | Behavioral: Exercise programmeThis will consist of an 8-week exercise programme, performed twice per week. |
| Usual Care | Placebo comparator | Behavioral: Exercise programmeStandard practice including opportunistic exercise advice and patients' self-directed physical activity |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programmeModerate intensity exercise | Behavioural | Exercise Programme, Usual Care |
Primary outcome
Modified Bruce Treadmill Test (Fitness)
Time frame: 0, 8 weeks, 3 months
5 secondary outcomes
FACT-G scale (Quality of life-overall)
Time frame: 0, 8 weeks, 3 months
FACT-F (Fatigue)
Time frame: 0, 8 weeks, 3 months
RT3 Accelerometry (Activity level)
Time frame: 0, 8 weeks, 3 months
Tanita Body Fat Assessment (% fat)
Time frame: 0, 8 weeks, 3 months
SF-36v2 (Quality of life-functional aspects)
Time frame: 0, 8 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
- Background: PubMed 20156345Walsh 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.
- Sponsor's web pageLink provided by the sponsor.
- University affiliated to this researchLink provided by the sponsor.
- Hospital affiliated to this researchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dearbhaile O' Donnell, MD principal investigator
St. James's Hospital, Dublin, Ireland
Juliette Hussey, PhD principal investigator
Trinity College Dublin, Ireland
Julie M Walsh, MSc principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise programme in people with Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Bruce Treadmill Test (Fitness) (time frame: 0, 8 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01030887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011; AzTrials last refreshed its copy on 1 Nov 2026.