MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capaci… (NCT01719562) | Clinical Trial Compass
CompletedNot Applicable
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
United States28 participantsStarted 2013-01-01
Plain-language summary
This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help doctors predict whether patients will have heart damage caused by chemotherapy in patients with cancer receiving chemotherapy.
Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility of performing the physical activity intervention and the primary outcome measures before, during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma. This study will test the potential for a novel (lifestyle) intervention designed to improve exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This data will inform the development of the R33 phase of the clinical trial to determine if the physical activity intervention can reduce exercise intolerance in this high-risk population. In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac MRI data from individuals in the parent study that did not undergo either of the two interventional arms of this study.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PARENT STUDY:
Inclusion Criteria:
* Receiving \>= 350 mg/m\^2 of Anth-bC therapy, or a combination of Anth-bC (\>= 250 mg/m\^2) and subsequent paclitaxel or Herceptin
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
* Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
* Allergy to gadolinium or other severe drug allergies
* Unstable angina
* Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/minute due to gating difficulty)
* Acute myocardial infarction within 28 days
* Atrial fibrillation with uncontrolled ventricular response
* Moderate or severe aortic stenosis
* Claustrophobia
* Congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
* Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy
* Participants unwilling to complete the protocol (24 month duration)
* Women who are pregnant
* Patients unable or unwilling to provide informed consent
EXERCISE CAPACITY ADDENDUM:
Inclusion Criteria:
* Men and women aged 18-85 with non- or Hodgkin lymphoma or I-IV stage breast cancer patients that expect to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens \[anthracyclines, trastuzum…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Completing the Trial (Exercise Capacity Addendum)
Timeframe: 6 months after treatment initiation
2
Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)