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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 : June 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Dietary Intervention Behavioral: Exercise Intervention Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Health of Women on Aromatase Inhibitors
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (dietary intervention)
Patients receive a controlled anti-inflammatory diet over 12 weeks.
Dietary Supplement: Dietary Intervention
Receive dietary intervention
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Questionnaire Administration
Ancillary studies

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.
Behavioral: Exercise Intervention
Receive exercise intervention

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: Baseline up to 1 week post intervention ]
    Will be scanned by dual x-ray absorptiometry (iDXA).

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953157


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Catherine L. Carpenter    310-825-8499    ccarpenter@sonnet.ucla.edu   
Principal Investigator: Catherine L. Carpenter         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Catherine L Carpenter UCLA / Jonsson Comprehensive Cancer Center

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03953157     History of Changes
Other Study ID Numbers: 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 )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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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

Additional relevant MeSH terms:
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Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs