High-Intensity Interval Training for Stage I-III Breast Cancer Patients
High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To assess the feasibility (completion of > 80% exercise sessions) of utilizing high-intensity interval training (HIT).
II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group.
III. To examine the effects of HIT on left ventricular function when compared to delayed group.
IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group.
OUTLINE: Participants are randomized to 1 of 2 groups.
ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30 minutes, thrice weekly for 8 weeks.
ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT exercise program as in Arm I.
After completion of study, patients are followed up at weeks 9 and 17.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90033
- USC / Norris Comprehensive Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English or Spanish speaking
- Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
- Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
- Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
- Physician (oncologist) clearance to participate in exercise at moderate to high intensity
- Have read and signed study informed consent document (ICF)
- EXERCISE INCLUSION CRITERIA:
- Normal body temperature (=< 100 degrees F)
- Resting blood pressure and/or heart rate within normal limits
- Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Exclusion Criteria:
- Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
- Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
- Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
- Moderate to highly active level of physical activity (e.g. currently participating in >= 60 minutes of moderate aerobic activity weekly)
- Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
- EXERCISE EXCLUSION CRITERIA:
- Presence of fever (>= 100 degrees F)
- Resting blood pressure and/or heart rate outside normal limits
- Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:ARM I (HIT group)
Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.
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相関研究
補助研究
他の名前:
補助研究
Undergo HIT
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アクティブコンパレータ:Arm II (Delayed group)
Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks.
Participants document their weekly activity in an exercise log.
Following completion of all study visits, participants are given the option to complete the HIT program as in Arm I.
|
相関研究
補助研究
他の名前:
補助研究
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
時間枠:Up to 17 weeks
|
The exercise program will be considered feasible if participants complete greater than 80% of exercise sessions.
Participant attendance rates will be used to establish compliance and will be used to provide a perspective on how and to what extent cancer patients will participate in an experimental exercise intervention and what variations in exercise intensities may be tolerated.
Feasibility will be assessed based on both program attendance as well as exercise time completed.
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Up to 17 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
時間枠:Baseline to up to week 17
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A mixed-effect regression model will be fit to compare the mean changes in VO2peak (ml/kg/min) between groups.
The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on VO2peak (ml/kg/min) over time will also be examined.
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Baseline to up to week 17
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Change in left ventricular function
時間枠:Baseline to up to week 17
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A mixed-effect model will be fit to compare the mean changes in left ventricular ejection fraction, left ventricular end-diastolic volume, left ventricular end-systolic volume, and peak filling time.
The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on left ventricular function over time will also be examined.
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Baseline to up to week 17
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協力者と研究者
捜査官
- 主任研究者:Christina Dieli-Conwright、University of Southern California
出版物と役立つリンク
一般刊行物
- Lee K, Norris MK, Wang E, Dieli-Conwright CM. Effect of high-intensity interval training on patient-reported outcomes and physical function in women with breast cancer receiving anthracycline-based chemotherapy. Support Care Cancer. 2021 Nov;29(11):6863-6870. doi: 10.1007/s00520-021-06294-7. Epub 2021 May 20.
- Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Dieli-Conwright CM. Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. BMC Cancer. 2019 Jul 3;19(1):653. doi: 10.1186/s12885-019-5887-7.
- Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Lu J, Dieli-Conwright CM. Effects of high-intensity interval training on vascular endothelial function and vascular wall thickness in breast cancer patients receiving anthracycline-based chemotherapy: a randomized pilot study. Breast Cancer Res Treat. 2019 Sep;177(2):477-485. doi: 10.1007/s10549-019-05332-7. Epub 2019 Jun 24.
- Lee K, Kang I, Mortimer JE, Sattler F, Mack WJ, Fitzsimons LA, Salem G, Dieli-Conwright CM. Effects of high-intensity interval training on vascular function in breast cancer survivors undergoing anthracycline chemotherapy: design of a pilot study. BMJ Open. 2018 Jun 30;8(6):e022622. doi: 10.1136/bmjopen-2018-022622.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1B-14-5 (その他の識別子:USC / Norris Comprehensive Cancer Center)
- P30CA014089 (米国 NIH グラント/契約)
- NCI-2015-00579 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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