Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer, Orthopedic |
| Therapuetic Areas: | Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | September 2015 |
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.
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.
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.
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.
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
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