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Preoperative Health & Body for Breast Cancer (PreHab Trial)

N/A
Waitlist Available
Led By Jennifer A Ligibel, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planning to undergo definitive surgical management with lumpectomy or mastectomy within the next 8 weeks
English speaking and able to read English
Must not have
Scheduled to receive any form of neoadjuvant cancer therapy
Presence of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trialwill study the effects of exercise and Mind-Body programs on how women with breast cancer feel and on markers in breast cancer cells and hormones in the blood. Results will not be shared with patients.

Who is the study for?
This trial is for English-speaking women with newly diagnosed stage I-III breast cancer, who are fit enough to exercise and can participate in the study for at least 3 weeks before surgery. They must not be receiving neoadjuvant therapy, have metastatic disease, or a recent history of other cancers except certain skin or cervical cancers.
What is being tested?
The study examines if short-term exercise or Mind-Body programs before breast surgery can improve stress, mood, quality of life and affect cancer cell markers. Women will be randomly assigned to these preoperative health interventions.
What are the potential side effects?
Since the interventions involve exercise and mind-body programs designed to reduce stress and improve well-being prior to surgery, significant side effects are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to remove breast cancer within 8 weeks.
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I can speak and read English.
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I am fully active or can carry out light work.
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I have been recently diagnosed with stage I-III breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for initial treatment before my main cancer treatment.
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My cancer has spread to other parts of my body.
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My breast cancer cannot be removed with initial surgery.
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I have had breast cancer in the same breast before.
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I was on tamoxifen, raloxifene, or an aromatase inhibitor when diagnosed with breast cancer.
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I have not been treated for any cancer other than non-melanoma skin or in situ cervical cancer in the past 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of intervention in women with newly diagnosed breast cancer
Impact of Exercise on Ki-67
Secondary study objectives
Impact of exercise on biomarkers
Impact of exercise on receptors

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Exercise GroupActive Control1 Intervention
Supervised exercise sessions and independent exercise
Group II: Mind-Body GroupActive Control1 Intervention
Surgical preparation program

Find a Location

Who is running the clinical trial?

Yale UniversityOTHER
1,927 Previous Clinical Trials
3,031,683 Total Patients Enrolled
25 Trials studying Breast Cancer
2,978 Patients Enrolled for Breast Cancer
Susan G. Komen Breast Cancer FoundationOTHER
67 Previous Clinical Trials
220,309 Total Patients Enrolled
40 Trials studying Breast Cancer
215,026 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,110 Previous Clinical Trials
358,249 Total Patients Enrolled
144 Trials studying Breast Cancer
20,156 Patients Enrolled for Breast Cancer
Jennifer A Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
221 Total Patients Enrolled
2 Trials studying Breast Cancer
221 Patients Enrolled for Breast Cancer
~3 spots leftby Dec 2025
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