Name: Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial
Creator: Trial Radar
Published: 2025-04-03
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

タイル表示

A Study of Blood Pressure Control During Cancer Treatment

募集中

治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。

治験番号 NCT06023576 は 乳癌、心毒性 に関する予防の研究で、第II相・第二段階介入研究臨床試験 です。現在は 募集中 で、2023年8月18日から開始しています。130 名の参加者 の募集が計画されています。この治験はメモリアル・スローン・ケタリングがんセンターによって主催され、2028年5月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月3日 です。

概要

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.

公式タイトル

Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial

疾患／病気

乳癌心毒性

その他の研究識別子

23-159

NCT番号

NCT06023576

開始日

2023-08-18

最終更新日

2025-04-03

終了予定日

2028-05-30

目標参加者数

130

試験の種類

介入研究

治験の相・段階

第II相・第二段階

状況

募集中

キーワード

Blood pressure
23-159

主目的

予防

割付方法

無作為化

介入モデル

並行割当

盲検化

なし（非盲検）

群（アーム）／介入

参加グループ/群

介入/治療法

実験的standard-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

血圧測定

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).

心エコー図

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.

バイオマーカー

Research blood samples will be collected at baseline, 3 months, and 6 months

実験的higher 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

血圧測定

心エコー図

At baseline, month 6, and month 12

Symptom-limited Cardiopulmonary Exercise Test

Quality of Life Measures

バイオマーカー

Research blood samples will be collected at baseline, 3 months, and 6 months

試験は何を測定していますか？

主要評価項目

評価指標	指標の説明	時間枠
mean change in systolic blood pressure (SBP) from baseline to 12 months	based upon in-office measurement	12 months

適格基準

対象年齢

成人, 高齢者

試験の最低年齢

18 Years

対象性別

女性

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.

メモリアル・スローン・ケタリングがんセンター

試験中央連絡先

連絡先: Anthony Yu, MD, 212-639-7932, [email protected]

連絡先: Jennifer Liu, MD, 212-639-8220

7 1カ国の場所

アメリカ合衆国

New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States