REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)

NCT ID: NCT02543294

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-10
• Study Completion Date: 2017-09-10

Brief Summary

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.

Detailed Description

If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:

• Your complete medical history will be recorded.
• You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
• You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
• You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
• You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
• You will be given instructions on how to gradually wean yourself off of your heart failure medication.
• You will be given a machine that you will use to measure your blood pressure at home.

You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.

At Month 1:

• You will have a physical exam, including measurement of your vital signs.
• You will complete the questionnaire about any symptoms you may be having.
• You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 2, 4, 6, 12, 18, and 30:

• You will have a physical exam, including measurement of your vital signs.
• You will complete the questionnaire about any symptoms you may be having.
• You will have an ECHO.
• You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 3 and 5, you will have a telephone follow-up with a member of the research team.

Length of Study Participation:

You may continue taking part in the study for up to 6 continuous months with follow-up visits at Months 12, 18, and 30. You will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study.

Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Heart Failure; Cancer Treatment Induced Left Ventricular Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anthracycline Treatment Group

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Group Type: EXPERIMENTAL

Echocardiograms

Intervention Type: DEVICE

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Electrocardiogram

Intervention Type: DEVICE

Electrocardiogram performed at baseline.

Symptom Questionnaire

Intervention Type: BEHAVIORAL

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Telephone Follow-Up

Intervention Type: BEHAVIORAL

Telephone follow-up by study staff at months 3 and 5.

Herceptin Treatment Group

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Group Type: EXPERIMENTAL

Echocardiograms

Intervention Type: DEVICE

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Electrocardiogram

Intervention Type: DEVICE

Electrocardiogram performed at baseline.

Symptom Questionnaire

Intervention Type: BEHAVIORAL

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Telephone Follow-Up

Intervention Type: BEHAVIORAL

Telephone follow-up by study staff at months 3 and 5.

Combination of Treatments Group

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Group Type: EXPERIMENTAL

Echocardiograms

Intervention Type: DEVICE

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Electrocardiogram

Intervention Type: DEVICE

Electrocardiogram performed at baseline.

Symptom Questionnaire

Intervention Type: BEHAVIORAL

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Telephone Follow-Up

Intervention Type: BEHAVIORAL

Telephone follow-up by study staff at months 3 and 5.

Interventions

Echocardiograms

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Intervention Type: DEVICE

Electrocardiogram

Electrocardiogram performed at baseline.

Intervention Type: DEVICE

Symptom Questionnaire

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Intervention Type: BEHAVIORAL

Telephone Follow-Up

Telephone follow-up by study staff at months 3 and 5.

Intervention Type: BEHAVIORAL

Other Intervention Names

ECHO; ECG; Survey

Eligibility Criteria

Inclusion Criteria

1. Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.

2. Prior diagnosis of CILVD with recovered LVEF (i.e. improved to > 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or B-blocker).

3. Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation

4. Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.

5. Age 18 - 80 years. HF clinical guidelines is supported by evidenced-based data from clinical trials which includes individuals up to 80 years of age.

6. Residence within the United States.

7. Ability to read and write English, because the MD Anderson Symptom Inventory -Heart Failure (MDASI-HF) instrument (Fadol et al., 2008) has been validated in English only.

Exclusion Criteria

1. Participants will be excluded if they have a recurrence that requires anti-cancer treatment.

2. Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis.

3. Exhibiting HF symptoms (e.g. shortness of breath, edema).

4. Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anecita Fadol, PHD, MSN

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

2012-0379

Identifier Type: -

Identifier Source: org_study_id