Chemotherapeutic ToxicityNCT05892146
Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction
A study testing Prevention therapy and Rescue therapy in people with Chemotherapeutic Toxicity and Cardiotoxicity, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chemotherapeutic Toxicity, Cardiotoxicity, Heart Failure
- What is being tested?
- Prevention therapy and Rescue therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are newly diagnosed with breast cancer or lymphoma and never accepted anti-cancer therapy
- Age 20-65 years old
- Systolic blood pressure ≥ 110 mmHg
Who cannot join
- End-stage renal disease (estimated Glomerulus Filtration Rate <15 mL/min/1.73 m2)
- Echocardiography Baseline left ventricle ejection fraction < 50%
- Allergy history to angiotensin receptor blockers
- Life expectancy < 1 year
- Pregnancy
- Unwilling to participate in this clinical study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
Ping-Yen Liu, PhD, +886-6-2353535 ext. 3656, larry@mail.ncku.edu.tw
Pei-Tien Hsu, +886-6-2353535 ext. 4602, sz2137@yahoo.com.tw
About this study
Official title: Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. The investigators planned an earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography. The investigators aim to assess the protective and therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.
Read the detailed description
The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. Also, the Patient Recruitment System support to complete the patients' database. The investigators cooperate with other hospitals in South Taiwan to carry on an early phase clinical trial, named "Strategy by novel anti-heart failure therapy on early phase Cancer Therapeutics-Related Cardiac Dysfunction (CTRCD) patients" focusing on the either preventive strategy to earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography, and collect clinical and genetic information from the enrolled patients. These patients randomized into 2 groups: cardioprotective drug vs. placebo. The regular assessment of cardiac function is as following: baseline (prior to anti-cancer treatment) and every 3 months. Thereafter. The investigators aim to assess the protective and/or therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.
- Being tested
- Prevention therapy, Rescue therapy
- Medical subject headings
- Cardiotoxicity, Heart Failure, Breast Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention therapyDrug
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Rescue therapyDrug
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Prevention therapy | Experimental | Sacubitril/Valsartan (25/80) mg twice a day for 1 year Receives: Drug: Prevention therapy |
| Conventional therapy | No intervention | No intervention |
| Global longitudinal strain (GLS) function decreased >15%, No intervention | No intervention | With the value of GLS function via echocardiography study decreased >15%, No intervention |
| GLS function descending >15%, Rescue therapy | Experimental | Sacubitril/Valsartan (25/80) mg twice a day for 1 year Receives: Drug: Rescue therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
Left ventricular global peak systolic longitudinal strain by cardiac echo
Measured: 1 year
Secondary outcomes (4)
Change in left ventricular ejection fraction value measured by echocardiography
Left ventricular ejection fraction by cardiac echo
Measured: 1 year
Heart failure hospitalization
admission due to heart function deterioration
Measured: 1 year
All-cause mortality
All types of death
Measured: 1 year
Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)
Cardiac biomarkers (NT-proBNP and hs-cTnT) changes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start5 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic ToxicityStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping-Yen Liu, National Cheng-Kung University Hospital
- Investigators
- Ping-Yen Liu, MD, PhD, Principal investigator, National Cheng Kung University Hospital, Tainan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892146
- Sponsor's protocol ID
- A-BR-110-021
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
- ClinicalTrials.gov ID
- NCT05892146
- Acronym / sponsor ID
- A-BR-110-021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. The investigators planned an earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography. The investigators aim to assess the protective and therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.
Detailed description
The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. Also, the Patient Recruitment System support to complete the patients' database. The investigators cooperate with other hospitals in South Taiwan to carry on an early phase clinical trial, named "Strategy by novel anti-heart failure therapy on early phase Cancer Therapeutics-Related Cardiac Dysfunction (CTRCD) patients" focusing on the either preventive strategy to earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography, and collect clinical and genetic information from the enrolled patients. These patients randomized into 2 groups: cardioprotective drug vs. placebo. The regular assessment of cardiac function is as following: baseline (prior to anti-cancer treatment) and every 3 months. Thereafter. The investigators aim to assess the protective and/or therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prevention therapy | Experimental | Drug: Prevention therapySacubitril/Valsartan (25/80) mg twice a day for 1 year |
| Conventional therapy | No intervention | –No intervention |
| Global longitudinal strain (GLS) function decreased >15%, No intervention | No intervention | –With the value of GLS function via echocardiography study decreased >15%, No intervention |
| GLS function descending >15%, Rescue therapy | Experimental | Drug: Rescue therapySacubitril/Valsartan (25/80) mg twice a day for 1 year |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are newly diagnosed with breast cancer or lymphoma and never accepted anti-cancer therapy
- Age 20-65 years old
- Systolic blood pressure ≥ 110 mmHg
Key exclusion criteria (6 listed)
- End-stage renal disease (estimated Glomerulus Filtration Rate <15 mL/min/1.73 m2)
- Echocardiography Baseline left ventricle ejection fraction < 50%
- Allergy history to angiotensin receptor blockers
- Life expectancy < 1 year
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention therapySacubitril/Valsartan (25/80) mg twice a day for 1 year | Drug | Prevention therapy |
| Rescue therapySacubitril/Valsartan (25/80) mg twice a day for 1 year | Drug | GLS function descending >15%, Rescue therapy |
Primary outcome
Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
Time frame: 1 year
Left ventricular global peak systolic longitudinal strain by cardiac echo
4 secondary outcomes
Change in left ventricular ejection fraction value measured by echocardiography
Time frame: 1 year
Heart failure hospitalization
Time frame: 1 year
All-cause mortality
Time frame: 1 year
Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Yen Liu, MD, PhD principal investigator
National Cheng Kung University Hospital, Tainan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention therapy and Rescue therapy in people with Chemotherapeutic Toxicity and Cardiotoxicity, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping-Yen Liu, PhD. (+8862353535 ext. 3656, larry@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.