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Diet and Exercise for Breast Cancer Side Effects

N/A
Waitlist Available
Led By Catherine L Carpenter
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with localized breast cancer, up to stage IIIa
At least 6 months post chemotherapy or radiation treatment
Must not have
Currently undergoing chemotherapy or radiation treatment
Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 week post intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well a diet and exercise plan can reduce side effects in breast cancer patients taking aromatase inhibitors.

Who is the study for?
This trial is for postmenopausal women with stage I-IIIa breast cancer who are currently taking aromatase inhibitors and experiencing joint pain. They should be in good health, at least 6 months past chemotherapy or radiation, not on bone loss medication, without severe bone density issues or fractures since starting AIs, and not already engaged in regular exercise.
What is being tested?
The study is testing if a special diet (Anti-inflammatory Mediterranean) combined with bone-strengthening exercises can reduce joint pain and improve heart function and bone density in patients taking aromatase inhibitors to potentially lower the chance of cancer coming back.
What are the potential side effects?
Since this trial involves dietary changes and exercise rather than drugs, side effects may include muscle soreness from new physical activities or digestive changes due to diet adjustments. No drug-related side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is at stage IIIa or below and has not spread widely.
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It has been over 6 months since my last chemotherapy or radiation treatment.
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I have had joint pain for at least 2 months.
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I have been on aromatase inhibitors for at least 6 months.
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I am postmenopausal, either naturally, through surgery, or due to treatment.
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I am currently on aromatase inhibitor medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving chemotherapy or radiation.
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I have physical limitations that stop me from fully participating in exercise.
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I am taking medication for bone loss.
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My bone density is low, I've had a fracture on AIs, or I'm using steroids.
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I do not have serious heart, lung, kidney, liver, or mental health conditions.
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I have been diagnosed with breast cancer that has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 week post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 week post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone mineral density
Inflammatory markers
Joint and muscle pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (exercise intervention)Experimental Treatment2 Interventions
Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.
Group II: Arm I (dietary intervention)Experimental Treatment2 Interventions
Patients receive a controlled anti-inflammatory diet over 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Exercise Intervention
2016
Completed Phase 4
~1330

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,185 Total Patients Enrolled
Catherine L CarpenterPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03953157 — N/A
Back Pain Research Study Groups: Arm II (exercise intervention), Arm I (dietary intervention)
Back Pain Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT03953157 — N/A
Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03953157 — N/A
~1 spots leftby Jun 2025
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