Breast CancerPreHabNCT01516190
The Preoperative Health & Body Study
A study testing Exercise and Surgical preparation program in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise and Surgical preparation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Exercise, Surgical preparation program
- Keywords
- stage I-III breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Supervised exercise sessions and independent exercise
Surgical preparation programBehavioural
Book, tapes, CD
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | Supervised exercise sessions and independent exercise Receives: Behavioral: Exercise |
| Mind-Body Group | Active comparator | Surgical preparation program Receives: Behavioral: Surgical preparation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Exercise on Ki-67
To explore the impact of exercise upon Ki-67, a tissue-based biomarker associated with breast cancer risk and progression.
Measured: 3 years
Feasibility of intervention in women with newly diagnosed breast cancer
To evaluate the feasibility of conducting a window of opportunity study utilizing exercise and mind-body intervention in women with newly diagnosed breast cancer
Measured: 3 years
Secondary outcomes (2)
Impact of exercise on biomarkers
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)
Measured: 3 years
Impact of exercise on receptors
To explore the impact of a 3-6 week exercise intervention upon expression of metabolic, sex steroid and related receptors in malignant breast tissue.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2015
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer A Ligibel, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516190
- Sponsor's protocol ID
- 11-182
- Acronym
- PreHab
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2012
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Knoerl R, Giobbie-Hurder A, Sannes TS, Chagpar AB, Dillon D, Dominici LS, Frank ES, Golshan M, McTiernan A, Rhei E, Tolaney SM, Winer EP, Yung RL, Irwin ML, Ligibel JA. Exploring the impact of exercise and mind-body prehabilitation interventions on physical and psychological outcomes in women undergoing breast cancer surgery. Support Care Cancer. 2022 Mar;30(3):2027-2036. doi: 10.1007/s00520-021-06617-8. Epub 2021 Oct 14.
PubMed 34648061
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preoperative Health & Body Study
- ClinicalTrials.gov ID
- NCT01516190
- Acronym / sponsor ID
- PreHab / 11-182
- Conditions
- Breast Cancer
- Keywords
- stage I-III breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Yale University, Susan G. Komen Breast Cancer Foundation
- Study start
- Aug 2011 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Behavioral: ExerciseSupervised exercise sessions and independent exercise |
| Mind-Body Group | Active comparator | Behavioral: Surgical preparation programSurgical preparation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSupervised exercise sessions and independent exercise | Behavioural | Exercise Group |
| Surgical preparation programBook, tapes, CD | Behavioural | Mind-Body Group |
Primary outcome
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.
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
2 secondary outcomes
Impact of exercise on biomarkers
Time frame: 3 years
Impact of exercise on receptors
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 34648061Knoerl R, Giobbie-Hurder A, Sannes TS, Chagpar AB, Dillon D, Dominici LS, Frank ES, Golshan M, McTiernan A, Rhei E, Tolaney SM, Winer EP, Yung RL, Irwin ML, Ligibel JA. Exploring the impact of exercise and mind-body prehabilitation interventions on physical and psychological outcomes in women undergoing breast cancer surgery. Support Care Cancer. 2022 Mar;30(3):2027-2036. doi: 10.1007/s00520-021-06617-8. Epub 2021 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Ligibel, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Surgical preparation program in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Exercise on Ki-67 (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.