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治験 NCT04458532（対象：早期乳癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
メモリアル・スローン・ケタリングがんセンターExercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.
A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer
- 20-130
Aerobic Training
Post-Menopausal Women
20-130
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的(A) breast cancer after completion of chemo 300 min/wk for 16 weeks, followed by 16 weeks of usual care. | 有酸素トレーニング 300 min/wk for 16 weeks |
実験的(B) breast cancer after completion of chemo 150 min/wk for 32 weeks. | 有酸素トレーニング 150 min/wk for 32 weeks |
実験的(C) breast cancer after completion of chemo 300 min/wk for 32 weeks. | 有酸素トレーニング 300 min/wk for 32 weeks |
実薬対照薬(D) breast cancer after completion of chemo 150 min/wk for 16 weeks, followed by 16 weeks of usual care. | 有酸素トレーニング 150 min/wk for 16 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate | A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change \<1.32 ml O2.kg-1.min-1 will be considered a non-response. | 32 weeks |
Aged 21-80 years
Female
Surgically resected early stage (I-III) primary breast cancer
Post-menopausal, defined as one of the following:
- Age ≥ 45 with no menses for at least 2 years
- Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist
- Estradiol level of ≤30 pg/mL
An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:
- Surgery plus radiation
- Surgery plus chemotherapy
- Surgery plus trastuzumab
Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)].
Note: Normative values are available up to 80 years of age)
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 in oxygen consumption, concurrent with an increase in power output;
- A respiratory exchange ratio ≥ 1.10;
- Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
- Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale
Willingness to comply with all study-related procedures.
Any of the following absolute contraindications to cardiopulmonary exercise testing:
- Acute myocardial infarction within 3-5 days of any planned study procedures
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)
Presence of any other concurrent, actively treated malignancy
History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
Presence of distant metastatic disease (i.e., stage IV)
Room air desaturation at rest ≤ 85%
Mental impairment leading to inability to cooperate.
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.
メモリアル・スローン・ケタリングがんセンター737 件のアクティブな治験を探索アメリカ国立がん研究所3030 件のアクティブな治験を探索Connecticut
New York