Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors
NCT ID: NCT03953157
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2019-10-07
2024-12-19
Brief Summary
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Detailed Description
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I. To recruit an ethnically, racially and culturally diverse sample of postmenopausal women diagnosed with estrogen receptor positive breast cancer who are currently taking aromatase inhibitor (AI), establish eligibility, and randomly allocate 20 participants to a two-arm parallel intervention trial.
II. Conduct baseline measurements of: body composition and bone mineral density, reported muscle and joint pain; inflammatory, cardiovascular and bone health markers contained in blood serum; and, cardiovascular function.
III. Conduct a three month anti-inflammatory dietary intervention in one arm, and bone strengthening exercise intervention in the other study arm.
IV. At completion of these 3-month interventions, evaluate changes since baseline of body composition, bone density, reported muscle and joint pain, and inflammatory and cardiovascular measurements within each intervention arm, and preliminarily contrast changes between intervention arms.
V. Utilize results from both intervention arms to design a larger 2x2 randomized factorial trial designed to assess effects of anti-inflammatory diet, effects of bone promoting exercise, and combined diet and exercise intervention effects on joint and muscle pain, inflammatory markers, bone mineral density, and cardiovascular measures.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a controlled anti-inflammatory diet over 12 weeks.
ARM II: Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.
After completion of study, patients are followed up at 1 week.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (dietary intervention)
Patients receive a controlled anti-inflammatory diet over 12 weeks.
Dietary Intervention
Receive dietary intervention
Questionnaire Administration
Ancillary studies
Arm II (exercise intervention)
Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.
Exercise Intervention
Receive exercise intervention
Questionnaire Administration
Ancillary studies
Interventions
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Dietary Intervention
Receive dietary intervention
Exercise Intervention
Receive exercise intervention
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with localized breast cancer, up to stage IIIa.
* Has been taking aromatase inhibitor (AIs) for at least six months.
* Has been experiencing mild to moderate arthralgia (joint pain) for at least 2 months determined by the Brief Pain Inventory (BPI).
* At least 6 months post chemotherapy or radiation treatment.
* Subjects must be in good health as determined by medical history, physical examination, iDXA scan and clinical laboratory measurements.
* Postmenopausal either natural or surgical or postmenopausal caused by ovarian suppression treatments administered to premenopausal women.
* Currently taking aromatase inhibitor medication.
Exclusion Criteria
* Currently undergoing chemotherapy or radiation treatment.
* Food allergies of any kind, or any medical condition requiring mandatory dietary restrictions.
* A bone mineral density (BMD) T score less than -1, or fracture since taking AIs, or current use of glucocorticoids.
* Taking bisphosphonates or any other medication for bone loss.
* Significant cardiac, pulmonary, renal, liver or psychiatric disease.
* Currently undergoing or engaging in a regular exercise program.
* Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise.
* Body mass index (BMI) greater than 40 kg/m\^2.
FEMALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Catherine L Carpenter
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2019-02909
Identifier Type: REGISTRY
Identifier Source: secondary_id
18-001926
Identifier Type: -
Identifier Source: org_study_id
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