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Behavioural Intervention

Exercise and Nutrition Regimen for Breast Cancer Recovery (EXERT-BCN Trial)

N/A

Recruiting

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast

Women undergoing active chemotherapy are not allowed on study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

EXERT-BCN Trial Summary

This trial aims to see if exercise and nutrition can improve breast cancer recovery for women.

Who is the study for?

This trial is for women aged 20-89 who have been treated for breast cancer with surgery, radiation, immunotherapy, or hormonal therapy. They must be able to perform resistance training and not currently undergoing chemotherapy.Check my eligibility

What is being tested?

The study tests a monitored exercise program combined with a nutrition plan focusing on food quality. It involves high-load resistance training and functional exercises designed to improve body composition after breast cancer treatment.See study design

What are the potential side effects?

Since the intervention includes exercise and nutritional changes rather than medication, side effects may include muscle soreness, fatigue from workouts, potential dietary adjustment issues but are generally expected to be minimal.

EXERT-BCN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of breast cancer.

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I am not currently undergoing chemotherapy.

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I am between 20 and 89 years old.

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I have undergone treatment for breast cancer, including surgery, radiation, chemotherapy, immunotherapy, or hormonal therapy.

EXERT-BCN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis

Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound

Secondary outcome measures

Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen

Determine changes in GAD7 anxiety score from before to after the nutrition and exercise regimen

Determine changes in PHQ9 depression score from before to after the nutrition and exercise regimen

+6 more

EXERT-BCN Trial Design

1Treatment groups

Experimental Treatment

Group I: Resistance training with high quality low-carbohydrate nutrition regimenExperimental Treatment1 Intervention

The regimen will consist of an intense resistance training program with linear progression and the goal of increase strength, mobility, muscle mass, and functional capacity. The nutrition program will avoid calorie counting, and instead focus on quality, while maximizing protein and limiting carbohydrates.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor

47 Previous Clinical Trials

13,035 Total Patients Enrolled

3 Trials studying Breast Cancer

8,070 Patients Enrolled for Breast Cancer

Media Library

Nutrition and resistance training exercise intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05978960 — N/A

Breast Cancer Research Study Groups: Resistance training with high quality low-carbohydrate nutrition regimen

Breast Cancer Clinical Trial 2023: Nutrition and resistance training exercise intervention Highlights & Side Effects. Trial Name: NCT05978960 — N/A

Nutrition and resistance training exercise intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05978960 — N/A

Frequently Asked Questions

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

Who meets the qualifications to join this investigation?

"To be eligible for this breast cancer research trial, prospective participants should be between 20 and 89 years old. 44 individuals in total are being sought after to participate."

Answered by AI

Does the eligibility for this trial extend beyond octogenarians?

"This trial requires that participants are between the ages of 20 and 89. However, there exist 68 studies specifically designed for those under 18, as well as 2589 trials tailored to elderly individuals aged 65 and above."

Answered by AI

Are researchers currently seeking participants for this study?

"According to the clinicaltrials.gov website, this medical trial is actively searching for participants; it was initially posted on May 20th of 2021 and revised most recently on July 31st 2021."

Answered by AI

What is the ultimate aim of this medical experiment?

"This medical trial, which will be completed within a three-month period, aims to ascertain variations in fat mass from pre-intervention scans. Secondary metrics include GAD7 anxiety ratings with 8 questions scored 0 - 3; PHQ9 depression analysis involving 10 queries graded 0 - 3; and EQ-5D responses assessed on 5 criteria (1 - 5) and an overall rating of health."

Answered by AI

What is the number of participants currently enrolled in this experiment?

"Affirmative. As per the information available on clinicaltrials.gov, this medical experiment is actively enrolling participants. It was first announced on May 20th 2023 and underwent its latest edit on July 31st of the same year. There are 44 spots open at one single site for enrolment in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EXERT-BCN: An Exercise and Nutrition Regimen to Designed to Improve Body Composition After Treatment for Breast Cancer

2023. "EXERT-BCN: An Exercise and Nutrition Regimen to Designed to Improve Body Composition After Treatment for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05978960.

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