Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954706
Status:
TERMINATED
Last Update Posted:
2015-11-26
First Post:
2013-09-27
Brief Title:
Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients
Sponsor:
Baltimore VA Medical Center
Organization:
Baltimore VA Medical Center
Study Overview
Official Title:
Pilot Trial of Aerobic and Resistance Exercise Training for the Primary Prevention of Musculoskeletal Side Effects From Aromatase Inhibitors in Postmenopausal Breast Cancer Patients
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCS2
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
Detailed Description:
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 230000 women in the United States will be diagnosed with invasive breast cancer and approximately 40000 with die1 Women with breast cancer frequently experience significant functional and metabolic declines during and after treatment due to cancer-related fatigue CRF stress and depression23 Cancer-related fatigue is associated with side effects from treatment pain functional disability sleep disturbances mood disturbances and co-morbid conditions4 Patients with CRF have declines in physical activity and function which significantly impacts quality of life QOL5 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 roles46
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 patients7 Estrogen deprivation however results in multiple side effects which may worsen fatigue and the functional and metabolic declines associated with cancer treatment8 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 effects9 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 prevention9 Exercise interventions in breast cancer patients also improve QOL decrease fatigue and increase physical function and strength1011 Understanding the role of exercise in AI side effect prevention will allow us to translate these findings into therapy guidelines
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 patients7 Estrogen deprivation however results in multiple side effects which may worsen fatigue and the functional and metabolic declines associated with cancer treatment8 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 effects9 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 prevention9 Exercise interventions in breast cancer patients also improve QOL decrease fatigue and increase physical function and strength1011 Understanding the role of exercise in AI side effect prevention will allow us to translate these findings into therapy guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG028747 | NIH | None | httpsreporternihgovquickSearchP30AG028747 |