Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients

NCT01954706 | Terminated DMC

• 2 other identifiers: HP-00056384P30AG028747
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• Fatigue

  Fatigue (questionnaires) and muscle performance (muscle strength, endurance, and function)

  Baseline

• Muscle performance (muscle strength, endurance, and function) Fatigue and Muscle Performance

  Fatigue (questionnaire) and muscle performance (muscle strength, endurance, and function)

  16 weeks

• Musculoskeletal symptoms (VASpain, HAQ-DI)

  Musculoskeletal symptoms (VASpain, HAQ-DI)

  16 weeks

Secondary Outcomes (2)

• Glucose Tolerance and Inflammation

  Baseline

• Glucose Tolerance and Inflammation

  16 weeks

Study Arms (2)

Structured Exercise

EXPERIMENTAL

Structured and supervised aerobic and resistance training 2 times per week

Other: Structured Exercise

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Structured Exercise OTHER

Structured and supervised aerobic and resistance training 2 times per week

Structured Exercise

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (11)

• Society AC. Cancer Facts & Figures 2013. Atlanta: American Cancer Society 2013.

  BACKGROUND

• Thomson CA, Thompson PA, Wright-Bea J, Nardi E, Frey GR, Stopeck A. Metabolic syndrome and elevated C-reactive protein in breast cancer survivors on adjuvant hormone therapy. J Womens Health (Larchmt). 2009 Dec;18(12):2041-7. doi: 10.1089/jwh.2009.1365.

  PMID: 20044868 BACKGROUND

• Curt GA. Impact of fatigue on quality of life in oncology patients. Semin Hematol. 2000 Oct;37(4 Suppl 6):14-7. doi: 10.1016/s0037-1963(00)90063-5.

  PMID: 11068951 BACKGROUND

• Cramp F, Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006145. doi: 10.1002/14651858.CD006145.pub2.

  PMID: 18425939 BACKGROUND

• Braithwaite D, Satariano WA, Sternfeld B, Hiatt RA, Ganz PA, Kerlikowske K, Moore DH, Slattery ML, Tammemagi M, Castillo A, Melisko M, Esserman L, Weltzien EK, Caan BJ. Long-term prognostic role of functional limitations among women with breast cancer. J Natl Cancer Inst. 2010 Oct 6;102(19):1468-77. doi: 10.1093/jnci/djq344. Epub 2010 Sep 22.

  PMID: 20861456 BACKGROUND

• Berger AM, Gerber LH, Mayer DK. Cancer-related fatigue: implications for breast cancer survivors. Cancer. 2012 Apr 15;118(8 Suppl):2261-9. doi: 10.1002/cncr.27475.

  PMID: 22488700 BACKGROUND

• Collado-Hidalgo A, Bower JE, Ganz PA, Cole SW, Irwin MR. Inflammatory biomarkers for persistent fatigue in breast cancer survivors. Clin Cancer Res. 2006 May 1;12(9):2759-66. doi: 10.1158/1078-0432.CCR-05-2398.

  PMID: 16675568 BACKGROUND

• Lin NU, Winer EP. Advances in adjuvant endocrine therapy for postmenopausal women. J Clin Oncol. 2008 Feb 10;26(5):798-805. doi: 10.1200/JCO.2007.15.0946.

  PMID: 18258989 BACKGROUND

• Dent SF, Gaspo R, Kissner M, Pritchard KI. Aromatase inhibitor therapy: toxicities and management strategies in the treatment of postmenopausal women with hormone-sensitive early breast cancer. Breast Cancer Res Treat. 2011 Apr;126(2):295-310. doi: 10.1007/s10549-011-1351-3. Epub 2011 Jan 20.

  PMID: 21249443 BACKGROUND

• Gaillard S, Stearns V. Aromatase inhibitor-associated bone and musculoskeletal effects: new evidence defining etiology and strategies for management. Breast Cancer Res. 2011 Mar 14;13(2):205. doi: 10.1186/bcr2818.

  PMID: 21457526 BACKGROUND

• Winters-Stone KM, Dobek J, Bennett JA, Nail LM, Leo MC, Schwartz A. The effect of resistance training on muscle strength and physical function in older, postmenopausal breast cancer survivors: a randomized controlled trial. J Cancer Surviv. 2012 Jun;6(2):189-99. doi: 10.1007/s11764-011-0210-x. Epub 2011 Dec 23.

  PMID: 22193780 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Susan Kesmodel, MD

  Baltimore VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)