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Lifestyle Intervention for Heart Failure
N/A
Waitlist Available
Led By Karen Basen-Engquist, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Previous chemotherapy that contributed to the development of heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether cancer survivors who receive education and training about exercise are more likely to change their lifestyle and improve symptoms of heart failure.
Who is the study for?
This trial is for cancer survivors over 18 living in or near Houston, who've finished treatment or are on maintenance chemo. They must have heart failure (NYHA I-III) possibly due to previous chemotherapy and be mentally oriented. Those with severe heart failure (NYHA IV), conditions making exercise unsafe, or unable to consent are excluded.Check my eligibility
What is being tested?
The study examines if lifestyle changes through education about exercise and dietary counseling can improve the lives of those with heart failure post-cancer treatment. Participants will receive either regular care or added training and advice on how to incorporate healthy habits.See study design
What are the potential side effects?
Since this trial involves exercise and diet modification rather than medication, side effects may include muscle soreness, fatigue from increased activity levels, potential dietary adjustment issues like changes in bowel habits but generally low risk of serious side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My heart failure was caused by previous chemotherapy.
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I have heart failure with symptoms or test results confirming it.
Select...
I have finished my cancer treatment or am only on long-term maintenance chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment/Attendance/Drop-Out Rates
Side effects data
From 2016 Phase 3 trial • 300 Patients • NCT0200856551%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment3 Interventions
Exercise Training + Dietary Counseling
Group II: Group 1Experimental Treatment1 Intervention
Usual Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Counseling
2011
Completed Phase 3
~1860
Exercise Training
2011
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,696 Total Patients Enrolled
6 Trials studying Heart Failure
232 Patients Enrolled for Heart Failure
Karen Basen-Engquist, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
2,526 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am aware of who I am, where I am, and the current time.I am 18 years old or older.My heart failure is severe, even with treatment.My heart failure was caused by previous chemotherapy.I have heart failure with symptoms or test results confirming it.You live in or plan to stay in the Houston area for at least the next 16 weeks.I have finished my cancer treatment or am only on long-term maintenance chemotherapy.I have been diagnosed with cancer.My doctor says it's unsafe for me to exercise due to my health or current treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the qualifying condition currently able to participate in this research?
"Unfortunately, this particular clinical study is no longer looking for patients, as reflected on clinicaltrials.gov. The trial was initially posted on February 11th, 2008 and updated for the last time on June 29th, 2022. There are 737 other trials that are currently seeking patients."
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