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

NCT03953157 | Completed

• 2 other identifiers: 18-001926NCI-2019-02909
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Arthralgia; Postmenopausal; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

• Bone mineral density

  Will be scanned by dual x-ray absorptiometry (iDXA).

  Baseline up to 1 week post intervention

• Joint and muscle pain

  Joint and muscle pain will be measured by the Brief Pain Inventory, a frequently administered assessment for studies of women on aromatase inhibitors (AIs). Participants will be asked about use of pain medication and supplements such as chondroitin and glucosamine. Subjects will also fill out standard visual analog scales to rate intensity of pain ranging from 1 to 10, as well as locate source of pain on standardized human figures available from International Society of Anesthetic Pharmacology. Additionally grip strength, a common marker of functional muscle and joint weakness, will be assessed using a dynamometer.

  Baseline up to 1 week post intervention

• Inflammatory markers

  Fasting blood samples will be collected at baseline and end of intervention. Serum markers, IL-6, Il-8, TNF-?, MCP-1, hs-CRP, leptin, TGFbeta, IL-1beta, and CRP will be quantified.

  Baseline up to 1 week post intervention

Study Arms (2)

Arm I (dietary intervention)

EXPERIMENTAL

Patients receive a controlled anti-inflammatory diet over 12 weeks.

Dietary Supplement: Dietary Intervention; Other: Questionnaire Administration

Arm II (exercise intervention)

EXPERIMENTAL

Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.

Behavioral: Exercise Intervention; Other: Questionnaire Administration

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Receive dietary intervention

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm I (dietary intervention)

Exercise Intervention BEHAVIORAL

Receive exercise intervention

Arm II (exercise intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm I (dietary intervention); Arm II (exercise intervention)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Catherine L Carpenter

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: October 7, 2019
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: June 18, 2025

Record last verified: 2024-12

Locations

US (1)