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Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients (BCS2)

2015年11月25日 更新者:Susan B. Kesmodel, MD、Baltimore VA Medical Center

Pilot Trial of Aerobic and Resistance Exercise Training for the Primary Prevention of Musculoskeletal Side Effects From Aromatase Inhibitors in Postmenopausal Breast Cancer Patients

Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women, and drug therapies, which block the production or effects of estrogen, are the mainstay of treatment in these patients. Due to their effectiveness in postmenopausal women, aromatase inhibitors (AIs) are the standard of care for long-term estrogen suppression in these patients. Estrogen deficiency, however, results in multiple side effects. Some of the most common side effects in women taking AIs are joint and muscle aches, which promote physical deconditioning. Because of the long term use of AIs in postmenopausal breast cancer patients and the improvements in cancer-related outcomes that are observed with their use, identifying methods to reduce these side effects to maintain adherence to treatment is important. Exercise interventions in breast cancer patients also improve quality of life and reduce fatigue. Understanding the role of exercise in AI side effect prevention will allow us to translate these findings into therapy guidelines.

調査の概要

詳細な説明

Breast cancer is the most common malignancy in women in the United States and is the second leading cause of cancer deaths. In 2013, an estimated 230,000 women in the United States will be diagnosed with invasive breast cancer and approximately 40,000 with die.1 Women with breast cancer frequently experience significant functional and metabolic declines during and after treatment due to cancer-related fatigue (CRF), stress and depression.2,3 Cancer-related fatigue is associated with side effects from treatment, pain, functional disability, sleep disturbances, mood disturbances and co-morbid conditions.4 Patients with CRF have declines in physical activity and function, which significantly impacts quality of life (QOL).5 The mechanisms underlying functional declines and fatigue in breast cancer patients are likely multifactorial, but deconditioning, sarcopenia, increases in inflammatory cytokines, insulin resistance, and changes in muscle and fat metabolism seem to play important roles.4,6

Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women, and endocrine therapies, which block the production or effects of estrogen, are the mainstay of treatment in these patients. Due to their superior efficacy in postmenopausal women, aromatase inhibitors (AIs) are the standard of care for long-term estrogen suppression in these patients.7 Estrogen deprivation, however, results in multiple side effects which may worsen fatigue and the functional and metabolic declines associated with cancer treatment.8 Some of the most common side effects in women taking AIs are musculoskeletal symptoms, including arthralgias and myalgias, which promote deconditioning and sarcopenia and their associated side effects.9 Because of the prolonged use of AIs in postmenopausal breast cancer patients and the improvements in cancer-related outcomes that are observed with their use, great efforts are taken to reduce AI induced musculoskeletal symptoms (AIMSS) to maintain adherence to treatment. While multiple strategies are used to manage AIMSS, current therapies mainly focus on interventions in patients who develop symptoms (tertiary prevention) rather than primary prevention.9 Exercise interventions in breast cancer patients also improve QOL, decrease fatigue, and increase physical function and strength.10,11 Understanding the role of exercise in AI side effect prevention will allow us to translate these findings into therapy guidelines.

研究の種類

介入

入学 (実際)

5

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Maryland
      • Baltimore、Maryland、アメリカ、21201
        • Baltimore VA Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  • At least mild fatigue in 2 of the 4 areas of the Piper Fatigue Scale (score ≥ 1-3)
  • Completion of standard surgery +/- chemotherapy for breast cancer (may undergo radiation therapy during study)
  • 25-OH vitamin D > 20 ng/ml
  • Histological evidence of stage I-III hormone receptor-positive breast cancer
  • Body Mass Index >/=18 and <50 kg/m2
  • 40-80 years of age
  • Non-smoking (non smoking for at least 12 months: cigarettes, cigars, pipes
  • Menopause over one year (absence of menses for 12 months or greater)
  • Sedentary (exercise no >60 min 2 times/week)

Exclusion Criteria:

  • Taking oral steroids, warfarin, or other medications interfering with fat metabolism that may not be safely discontinued temporarily for specific produces (i.e. for 72 hours prior)
  • Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension (systolic blood pressure over 180 mm HG)unless medically stabilized
  • Participant is, in the opinion of the investigator, unable to adhere to the study protocol due to medical or orthopedic conditions that limit ability to exercise or travel to the Baltimore VA for protocol procedures
  • Chronic pulmonary disease (on supplemental O2)
  • Abnormal renal function (BUN above 40 mg/dl, Cr above 1.3 mg/dl, CrCl<60mg/dl)
  • Unstable lymphedema
  • Evidence of cancer metastases or recurrence
  • Anemia HCT below 30 mg/dl, platelets below 80,000/cm3
  • Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes, HgA1c>10%
  • Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120 mm HG, or other contraindications to exercise) confirmed with further diagnostic evaluations.
  • Abnormal liver function
  • Untreated dyslipidemia with National Cholesterol ATPIII 10 year cardiac risk score greater than 10% (www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm)
  • Metal implants or devices (i.e. pacemaker) if undergoing CT scan
  • History of seizures or taking anti-seizure or anti convulsion medication
  • Allergic to lidocaine
  • Mini-mental state examination below 24, dementia, or unstable clinical depression by exam

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:防止
  • 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
実験的:Structured Exercise
Structured and supervised aerobic and resistance training 2 times per week
Structured and supervised aerobic and resistance training 2 times per week
アクティブコンパレータ:Usual Care
Subjects will be counseled on American Cancer Society and American College of Sports Medicine physical activity and nutritional guidelines at the initiation of the study. Study participants will be contacted by a physician or nurse on weeks 2, 6, 10, and 14 to provide support and encouragement to patients.
Subjects will be counseled on American Cancer Society and American College of Sports Medicine physical activity and nutritional guidelines at the initiation of the study. Study participants will be contacted by a physician or nurse on weeks 2, 6, 10, and 14 to provide support and encouragement to patients.

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
Fatigue
時間枠:Baseline
Fatigue (questionnaires) and muscle performance (muscle strength, endurance, and function)
Baseline
Muscle performance (muscle strength, endurance, and function) Fatigue and Muscle Performance
時間枠:16 weeks
Fatigue (questionnaire) and muscle performance (muscle strength, endurance, and function)
16 weeks
Musculoskeletal symptoms (VASpain, HAQ-DI)
時間枠:16 weeks
Musculoskeletal symptoms (VASpain, HAQ-DI)
16 weeks

二次結果の測定

結果測定
時間枠
Glucose Tolerance and Inflammation
時間枠:Baseline
Baseline
Glucose Tolerance and Inflammation
時間枠:16 weeks
16 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Susan Kesmodel, MD、Baltimore VAMC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年11月1日

一次修了 (実際)

2015年9月1日

研究の完了 (実際)

2015年9月1日

試験登録日

最初に提出

2013年9月27日

QC基準を満たした最初の提出物

2013年9月27日

最初の投稿 (見積もり)

2013年10月7日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年11月26日

QC基準を満たした最後の更新が送信されました

2015年11月25日

最終確認日

2015年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • HP-00056384
  • P30AG028747 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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