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Behavioural Intervention

Stop Group for Cancer (STOP-MED Trial)

Phase 4
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer treatments with potential risk for CTRCD
Prior cancer therapy with anthracyclines and/ or HER2-targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 5 years
Awards & highlights

STOP-MED Trial Summary

This trial is studying whether it is safe for cancer survivors with heart problems to stop taking their heart failure medications once their heart function has returned to normal. Currently, there is not enough scientific evidence in this

Who is the study for?
This trial is for cancer survivors who've had heart issues (CTRCD) due to cancer therapy but now have normal heart function. They should have completed their cancer treatment and be on heart medications with no other reason, like kidney disease, to keep taking them.Check my eligibility
What is being tested?
The study tests if it's safe for these patients to stop taking their heart failure meds compared to those who continue. It involves regular check-ups and cardiac MRIs over five years to see if there's any difference in the return of heart problems between the two groups.See study design
What are the potential side effects?
While not directly about side effects, stopping meds may lead to risks like the return of heart dysfunction. Continuing meds can cause dizziness, fatigue, financial burden, and managing long-term medication schedules.

STOP-MED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I finished cancer treatment over 6 months ago and have no plans for more treatments that could affect my heart.
Select...
I have previously received treatment with anthracyclines or drugs targeting HER2.
Select...
I had a heart condition with reduced function after cancer treatment, diagnosed within the last year.

STOP-MED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cancer Therapy Related Cardiac Dysfunction Relapse
Secondary outcome measures
Changes in cardiac magnetic resonance parameters
Cost effectiveness analysis
Left ventricular diastolic function
+2 more
Other outcome measures
Changes in quality of life score
Clinical heart failure
Impact of gender
+3 more

Side effects data

From 2022 Phase 4 trial • 58 Patients • NCT04290624
4%
COVID-19
4%
Lower respiratory tract infection
4%
Headache
4%
Burn oral cavity
4%
Hypercholesterolemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Non-intervention Group

STOP-MED Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stop GroupExperimental Treatment1 Intervention
This group will stop their heart failure medication(s) under the supervision of the study team. The investigators expect most participants in the STOP group to only be on beta-blockers and/or angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). The ACEi or ARB will be stopped first. The ACEi or ARB will be reduced by 50% every 7 days and stopped 7 days after 25% of maximal recommended dose for HF is reached. At this point (or at baseline if only on BB), the BB dose will be reduced by 50% every 7 days then stopped once 25% of the maximal dose is reached.
Group II: Standard of Care GroupActive Control1 Intervention
This group with continue with their heart failure medication(s) for at least 1 year.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
484,845 Total Patients Enrolled
Unity Health TorontoOTHER
540 Previous Clinical Trials
447,445 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,666 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this ongoing medical study?

"According to clinicaltrials.gov, this particular trial is not actively seeking participants at the moment. Its initial posting was on January 1st, 2024, and it was last updated on December 13th, 2023. However, there are currently 1328 other ongoing clinical trials that are accepting candidates for participation."

Answered by AI

Are there multiple medical facilities throughout the United States conducting this clinical trial?

"Regarding patient recruitment, there are 10 medical facilities actively enrolling participants in this clinical trial. Notable locations include Foothills Medical Centre in Calgary, Baker Heart and Diabetes Institute in Melbourne, and St. Boniface Hospital in Winnipeg, along with an additional 10 sites."

Answered by AI

Has the Stop Group received official approval from the FDA?

"Based on our assessment, the safety of Stop Group is rated as 3, given that this trial falls under Phase 4 which indicates an approved treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The STOP-MED CTRCD Trial
2024. "The STOP-MED CTRCD Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06183437.
~223 spots leftby Dec 2027
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