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Diet and Exercise for Breast Cancer Side Effects

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 week post intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 week post intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bone mineral density

Inflammatory markers

Joint and muscle pain

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,692 Total Patients Enrolled

24 Trials studying Breast Cancer

1,758 Patients Enrolled for Breast Cancer

Catherine L CarpenterPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03953157 — N/A

Breast Cancer Research Study Groups: Arm II (exercise intervention), Arm I (dietary intervention)

Breast Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots to join this experiment?

"According to clinicaltrials.gov, the search for participants is ongoing with this study being initially posted on October 7th 2019 and most recently updated on June 23rd 2022."

Answered by AI

How many people have been recruited to participate in this experiment?

"Yes, the data posted on clinicaltrials.gov confirms that this study is currently seeking participants. The trial was first announced on October 7th 2019 and underwent its most recent update on June 23rd 2022. They are looking for 20 people at one site to join in the research effort."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03953157.

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