Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES: 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. ;


Study Design


Related Conditions & MeSH terms

  • 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
  • Breast Neoplasms
  • 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

NCT number NCT03953157
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact Gail Thames
Phone 310-825-0453
Email gthames@mednet.ucla.edu
Status Recruiting
Phase N/A
Start date October 7, 2019
Completion date June 1, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06113016 - Prevention of Frailty With Fisetin and Exercise (PROFFi) in Breast Cancer Survivors Phase 2
Recruiting NCT04290897 - Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors Phase 2
Active, not recruiting NCT04535323 - Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer Phase 1
Recruiting NCT05464810 - Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Early Phase 1
Active, not recruiting NCT04249622 - Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer Phase 2
Recruiting NCT05929768 - Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer Phase 3
Withdrawn NCT03666819 - Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy Phase 2
Recruiting NCT04862585 - Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel Phase 2/Phase 3
Recruiting NCT04593277 - Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study N/A
Active, not recruiting NCT05086731 - Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer N/A
Recruiting NCT05368428 - Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer N/A
Active, not recruiting NCT04086875 - A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer N/A
Completed NCT00507923 - Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer N/A
Recruiting NCT06058377 - Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer Phase 3
Recruiting NCT05455658 - STEMVAC in Patients With Early Stage Triple Negative Breast Cancer Phase 2
Active, not recruiting NCT04537312 - Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM) N/A
Recruiting NCT05674578 - Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors N/A
Active, not recruiting NCT05012176 - An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors N/A
Withdrawn NCT04205071 - Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer Phase 1
Active, not recruiting NCT01334021 - Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer Phase 2