Cardiac ToxicityNCT00728429
Aerobic Exercise in Patients Receiving Chemotherapy for Cancer
A study testing exercise intervention in people with Cardiac Toxicity and Chemotherapeutic Agent Toxicity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health. PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2009
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patients with cancer scheduled to receive 4-6 courses of an anthracycline-based chemotherapy
PATIENT CHARACTERISTICS:
- Able to pedal a stationary bicycle
- No severe hypertension (systolic blood pressure > 220 mm Hg or diastolic blood pressure >120 mm Hg)
- No atrial fibrillation with an uncontrolled ventricular response
- No ventricular arrhythmias
- No unstable angina
- No acute myocardial infarction within the past 28 days of enrollment
- No severe valvular heart disease
- No severe (exercise-limiting) peripheral vascular disease
- No severe pulmonary disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health.
PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.
Read the detailed description
OBJECTIVES:
- To determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy.
- To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer.
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
- Arm I (exercise): Patients undergo supervised aerobic exercise (walk or bicycle) 3 days a week concurrently with standard anthracycline-based chemotherapy for approximately 18-24 weeks.
- Arm II (non-exercise): Patients receive standard anthracycline-based chemotherapy for approximately 18-24 weeks.
Patients undergo peak ventilatory oxygen uptake (VO_2) by exercise bike test with gas exchange analysis at baseline and at 2 weeks after completion of anthracycline-based chemotherapy.
- Conditions
- Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- exercise intervention
- Keywords
- cardiac toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
24 week program of exercise
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | normal anthracycline therapy |
| exercise program | Experimental | Not described Receives: Behavioral: exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients enrolling in the study
Measured: day 1
Percentage of patients completing the study
Measured: 24 weeks
V02 peak before and after chemotherapy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gretchen Wells, MD, PhD, Principal investigator, Wake Forest University Health SciencesPeter H. Brubaker, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728429
- Sponsor's protocol ID
- CDR0000601334
- Other IDs
- CCCWFU-99108, CCCWFU-IRB-IRB00006209
- Status last verified
- Feb 2017
- First submitted
- 2 Aug 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
- ClinicalTrials.gov ID
- NCT00728429
- Acronym / sponsor ID
- CDR0000601334
- Conditions
- Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- cardiac toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Aug 2008 (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.
RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health.
PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.
Detailed description
OBJECTIVES:
- To determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy.
- To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer.
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
- Arm I (exercise): Patients undergo supervised aerobic exercise (walk or bicycle) 3 days a week concurrently with standard anthracycline-based chemotherapy for approximately 18-24 weeks.
- Arm II (non-exercise): Patients receive standard anthracycline-based chemotherapy for approximately 18-24 weeks.
Patients undergo peak ventilatory oxygen uptake (VO_2) by exercise bike test with gas exchange analysis at baseline and at 2 weeks after completion of anthracycline-based chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | –normal anthracycline therapy |
| exercise program | Experimental | Behavioral: exercise intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 intervention24 week program of exercise | Behavioural | exercise program |
Primary outcome
Percentage of patients enrolling in the study
Time frame: day 1
Percentage of patients completing the study
Time frame: 24 weeks
V02 peak before and after chemotherapy
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
Gretchen Wells, MD, PhD principal investigator
Wake Forest University Health Sciences
Peter H. Brubaker, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention in people with Cardiac Toxicity and Chemotherapeutic Agent Toxicity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 30 May 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
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?
Percentage of patients enrolling in the study (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.