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

25. November 2015 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

5

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • Baltimore VA Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Structured Exercise
Structured and supervised aerobic and resistance training 2 times per week
Sonstiges: Structured Exercise
Structured and supervised aerobic and resistance training 2 times per week
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Glucose Tolerance and Inflammation
Zeitfenster: Baseline
Baseline
Glucose Tolerance and Inflammation
Zeitfenster: 16 weeks
16 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Baltimore VA Medical Center

Mitarbeiter

National Institute on Aging (NIA)

Ermittler

  • Hauptermittler: Susan Kesmodel, MD, Baltimore VAMC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2013

Primärer Abschluss (Tatsächlich)

1. September 2015

Studienabschluss (Tatsächlich)

1. September 2015

Studienanmeldedaten

Zuerst eingereicht

27. September 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. September 2013

Zuerst gepostet (Schätzen)

7. Oktober 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. November 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. November 2015

Zuletzt verifiziert

1. November 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HP-00056384
  • P30AG028747 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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