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Memorial Sloan Kettering KrebszentrumA Study of Blood Pressure Control During Cancer Treatment
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06023576 untersucht Prävention im Zusammenhang mit Brustkrebs, Kardiotoxizität. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 18. August 2023. Es ist geplant, 130 Teilnehmer aufzunehmen. Durchgeführt von Memorial Sloan Kettering Krebszentrum wird der Abschluss für 30. Mai 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. April 2025 aktualisiert.
Kurzbeschreibung
The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer.
The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.
Offizieller Titel
Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
Erkrankungen
BrustkrebsKardiotoxizitätWeitere Studien-IDs
- 23-159
NCT-Nummer
Studienbeginn (tatsächlich)
2023-08-18
Zuletzt aktualisiert
2025-04-03
Studienende (vorauss.)
2028-05-30
Geplante Rekrutierung
130
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
Blood pressure
23-159
23-159
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Experimentellstandard-of-care antihypertensive medications SBP control will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. | Antihypertensive Medications One or more of the following medications may be used in both randomization groups to achieve SBP goals:
* Angiotensin converting enzyme inhibitors (ACEI)
* Angiotensin receptor blockers (ARBs)
* Beta-blockers (BB)
* Thiazide-type diuretics
* Calcium channel blockers
* Aldosterone antagonists
* Alpha1-receptor blockers.
* Direct vasodilators
* Loop diuretics Blutdruckmessung Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part). Echokardiogramm At baseline, month 6, and month 12 Symptom-limited Cardiopulmonary Exercise Test Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met. Quality of Life Measures FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months. Biomarker Research blood samples will be collected at baseline, 3 months, and 6 months |
Experimentellhigher dose antihypertensive medications Patients randomized to intensive SBP control will be treated to achieve an SBP goal \<120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal \<140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider. | Antihypertensive Medications One or more of the following medications may be used in both randomization groups to achieve SBP goals:
* Angiotensin converting enzyme inhibitors (ACEI)
* Angiotensin receptor blockers (ARBs)
* Beta-blockers (BB)
* Thiazide-type diuretics
* Calcium channel blockers
* Aldosterone antagonists
* Alpha1-receptor blockers.
* Direct vasodilators
* Loop diuretics Blutdruckmessung Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part). Echokardiogramm At baseline, month 6, and month 12 Symptom-limited Cardiopulmonary Exercise Test Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met. Quality of Life Measures FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months. Biomarker Research blood samples will be collected at baseline, 3 months, and 6 months |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
mean change in systolic blood pressure (SBP) from baseline to 12 months | based upon in-office measurement | 12 months |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
Age ≥ 18 years
Female assigned at birth
Biopsy proven breast cancer (stage I-IV)
Treatment with therapy anthracycline-based chemo (with or without HER2-targeted therapy), with >/= 2 cycles of anthracycline chemotherapy planned.
SBP ≥130 mm Hg
Willing and able to comply with the requirements of the protocol.
Participant must have and be willing to use their bluetooth enabled wifi or cellular mobile device
(For participants in the CPET cohort): Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:
- Achieving a plateau oxygen consumption, concurrent with an increase in power output;
- A respiratory exchange ratio ≥ 1.10;
- Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age[years]);
- Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
eGFR < 30 ml/min/1.73m2 (based upon Cockcroft-Gault, etc.)
Individuals with arm circumference too large to allow accurate BP measurement with available BP devices
Inability to accurately measure blood pressure in at least one arm (e.g., bilateral upper extremity lymphedema)
Cardiac comorbidity, including any of the following:
- Acute coronary syndrome within 3 months prior to randomization.
- Symptomatic heart failure (NYHA class III/IV) within past 6 months
- History of stroke
- Cardiac transplantation
Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or adhere to study interventions
(For participants in the CPET cohort): Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
- Acute myocardial infarction (within 30 days of any planned study procedures),
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
- Symptomatic severe aortic stenosis
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
- Thrombosis of lower extremities (within 3 months of any planned study procedures)
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Room air desaturation at rest ≤85%
- Respiratory failure
- Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- Mental impairment leading to inability to cooperate.
Memorial Sloan Kettering Krebszentrum737 aktive klinische Studien zum ErkundenZentrale Studienkontakte
Kontakt: Anthony Yu, MD, 212-639-7932, [email protected]
Kontakt: Jennifer Liu, MD, 212-639-8220
7 Studienstandorte in 1 Ländern
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung
New York
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York, 11725, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Rockville Centre, New York, 11553, United States
Anthony Yu, MD, Kontakt, 212-639-7932
Offene Rekrutierung