The Preoperative Health & Body Study (PreHab)
November 19, 2025 updated by: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
This study is designed to look at the changes that occur in women who take part in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators will look at changes in stress, anxiety, mood and quality of life, to see if these types of short programs can make women feel better during this time. The investigators are also interested in looking at whether a short exercise or Mind-Body program leads to any changes in markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development.
Since the investigators do not know if these blood or tumor tests have any relationship to cancer recurrence, the investigators do not plan to share the results of these tests with you or your physician.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Newly diagnosed, histologically confirmed stage I-III breast cancer
- Planning to undergo definitive surgical management with lumpectomy or mastectomy with in the next 8 weeks.
- Willing and able to participate in the intervention for at least 3 weeks prior to surgery.
- ECOG performance status of 0 or 1
- Approval by oncologist or surgeon
- Willingness to be randomized.
- English speaking and able to read English
Exclusion Criteria:
- Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in situ cervical cancer)
- Presence of metastatic disease
- Scheduled to receive any form of neoadjuvant cancer therapy
- Locally advanced breast cancer not amenable to primary surgery
- History of prior ipsilateral breast cancer
- Taking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer diagnosis
- Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society
- Any condition which in the investigator's opinion makes the subject unsuitable for study participation
- Participating in another clinical study with competing study outcomes
- Pregnant (i.e., positive beta-HCG) or breast feeding
- Unable to comply with protocol and/or not available for follow-up assessments
- Participation in more than 90 minutes a week of moderate-intensity recreational activity (not including activities such as gardening, bowling, golfing with a cart) as assessed by the Leisure Score Index of Godin Leisure- Time Exercise Questionnaire (LSI) (Appendix I) or recent participation (past 6 months) in two or more strength training sessions per week.
- Diabetes mellitus requiring insulin or oral agents; patients with diet-controlled diabetes will be allowed to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise Group
Supervised exercise sessions and independent exercise
|
Supervised exercise sessions and independent exercise
|
|
Active Comparator: Mind-Body Group
Surgical preparation program
|
Book, tapes, CD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Exercise on Ki-67
Time Frame: 3 years
|
To explore the impact of exercise upon Ki-67, a tissue-based biomarker associated with breast cancer risk and progression.
|
3 years
|
|
Feasibility of intervention in women with newly diagnosed breast cancer
Time Frame: 3 years
|
To evaluate the feasibility of conducting a window of opportunity study utilizing exercise and mind-body intervention in women with newly diagnosed breast cancer
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of exercise on biomarkers
Time Frame: 3 years
|
To evaluate the impact of a 3-6 week intensive exercise intervention upon concentrations of serum matabolic and inflammatory biomarkers (insulin, glucose, IGF-1, IGFBP's, IL-2, IL-6, CRP, TNFa)
|
3 years
|
|
Impact of exercise on receptors
Time Frame: 3 years
|
To explore the impact of a 3-6 week exercise intervention upon expression of metabolic, sex steroid and related receptors in malignant breast tissue.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer A Ligibel, MD, Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
January 19, 2012
First Submitted That Met QC Criteria
January 23, 2012
First Posted (Estimated)
January 24, 2012
Study Record Updates
Last Update Posted (Estimated)
November 24, 2025
Last Update Submitted That Met QC Criteria
November 19, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-182
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.