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

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ClinicalTrials.gov Identifier: NCT03953157
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 16, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Bone mineral density [ Time Frame: Baseline up to 1 week post intervention ]
    Will be scanned by dual x-ray absorptiometry (iDXA).
  • Joint and muscle pain [ Time Frame: Baseline up to 1 week post intervention ]
    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.
  • Inflammatory markers [ Time Frame: Baseline up to 1 week post intervention ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors
Official Title  ICMJE Improving Health of Women on Aromatase Inhibitors
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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Dietary Supplement: Dietary Intervention
    Receive dietary intervention
    Other Names:
    • Dietary Modification
    • intervention, dietary
    • Nutrition Intervention
    • Nutrition Interventions
    • Nutritional Interventions
  • Behavioral: Exercise Intervention
    Receive exercise intervention
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (dietary intervention)
    Patients receive a controlled anti-inflammatory diet over 12 weeks.
    Interventions:
    • Dietary Supplement: Dietary Intervention
    • Other: Questionnaire Administration
  • Experimental: 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.
    Interventions:
    • Behavioral: Exercise Intervention
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953157
Other Study ID Numbers  ICMJE 18-001926
NCI-2019-02909 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18-001926 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Catherine L Carpenter UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP