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Biomarker-Guided Intervention for Chemotherapy Toxicity in Cancer Patients (NTproBNP-Guide Trial)
Phase 1 & 2
Waitlist Available
Led By Bonnie Ky, MD, MSCE
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (expected to be 1 year)
Awards & highlights
NTproBNP-Guide Trial Summary
This trial will test whether a biomarker-guided cardioprotection strategy using NTproBNP is safe and feasible for breast cancer and lymphoma patients treated with anthracyclines, as compared to usual care.
Who is the study for?
This trial is for adults over 18 with breast cancer or lymphoma who are about to start anthracycline chemotherapy. They must be willing to follow the study plan and not have severe heart, liver, kidney issues, uncontrolled high blood pressure, or be in late-stage cancer. Pregnant or breastfeeding women can't join, and those able to have children must use birth control.Check my eligibility
What is being tested?
The study tests a new way of protecting the heart using NTproBNP biomarker levels to guide treatment during chemotherapy for breast cancer and lymphoma patients compared to standard care without this guidance.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to usual care cardioprotective measures taken as part of the biomarker-guided strategy versus standard treatments.
NTproBNP-Guide Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (expected to be 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (expected to be 1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence rate
Compliance rate
Incidence of Adverse Events
+3 moreSecondary outcome measures
Change in Left ventricular ejection fraction (LVEF) by Echocardiogram
Body Weight Changes
Frequency of cancer treatment interruptions
+2 moreOther outcome measures
Change in Growth Differentiation Factor 15 (GDF-15)
Change in NTproBNP (post hoc batch analysis)
Change in circumferential strain
+10 moreNTproBNP-Guide Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biomarker Guided ArmExperimental Treatment1 Intervention
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
Group II: Usual CareActive Control1 Intervention
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
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Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,994 Total Patients Enrolled
14 Trials studying Lymphoma
303 Patients Enrolled for Lymphoma
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,594 Total Patients Enrolled
15 Trials studying Lymphoma
312 Patients Enrolled for Lymphoma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,541 Total Patients Enrolled
41 Trials studying Lymphoma
7,924 Patients Enrolled for Lymphoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am willing and able to follow all study rules and attend all appointments.Your average systolic blood pressure is less than 90mmHg in the month before joining the study.I have breast cancer or lymphoma and will start anthracycline chemotherapy.I am not pregnant or breastfeeding and will use effective birth control during the study.My blood pressure is very high despite taking three or more blood pressure medications.I do not have severe liver issues, end-stage kidney failure, very high potassium levels, a history of kidney transplant, extremely low kidney function, or severe heart failure.My breast cancer is at stage IV.You have had or currently have another type of cancer that may affect the safety or effectiveness of the new treatment being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Biomarker Guided Arm
- Group 2: Usual Care
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment still recruiting participants?
"According to clinicaltrials.gov, recruitment for this study is currently ongoing. The trial was first submitted on March 18th 2021 and underwent its most recent edit July 29th 2022."
Answered by AI
How many volunteers are participating in this experiment?
"Affirmative. According to information posted on clinicaltrials.gov, this medical study is now recruiting participants; the trial was first publicized on March 18th 2021 and has been recently updated July 29th 2022. Currently 100 subjects need to be recruited from 3 different sites."
Answered by AI
What aims are being sought with the implementation of this experiment?
"The principal endpoint of this research is focused on determining the maximal tolerated dose. Additionally, researchers are tracking frequency of cancer treatment interruptions due to cardiotoxicity, incidence of heart failure and change in left ventricular ejection fraction (LVEF) over a one-year period of study completion."
Answered by AI
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