Open Actively Recruiting

Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors

About

Brief Summary

This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.

Primary Purpose
Supportive Care
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
N/A

Inclusion Criteria:

  • At least 6 months since breast cancer diagnosis up to 2 years since diagnosis.
  • 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:

  • Diagnosed with metastatic breast cancer.
  • 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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
18-001926
Category
Oncology
School of Nursing
Principal Investigator
Catherine Carpenter
Contact
Gail Thames
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03953157
For detailed technical eligibility, visit ClinicalTrials.gov.