NCT03953157Completed
Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors
Improving Health of Women on Aromatase Inhibitors
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 15 May 2019
- Start date
- 7 Oct 2019
- Primary completion date
- 19 Dec 2024
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT03953157
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 7 Oct 2019 to the primary completion date, 19 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently undergoing chemotherapy or radiation treatment.
- Taking bisphosphonates or any other medication for bone loss.
Other illness
- Diagnosed with metastatic breast cancer.
- Food allergies of any kind, or any medical condition requiring mandatory dietary restrictions.
- Significant cardiac, pulmonary, renal, liver or psychiatric disease.
Other
- A bone mineral density (BMD) T score less than -1, or fracture since taking AIs, or current use of glucocorticoids.
- 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.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.