The Preoperative Health & Body Study (PreHab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01516190
Recruitment Status : Recruiting
First Posted : January 24, 2012
Last Update Posted : June 2, 2016
Yale University
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute

Brief 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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Exercise Behavioral: Surgical preparation program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Preoperative Health & Body Study
Study Start Date : August 2011
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Exercise Group
Supervised exercise sessions and independent exercise
Behavioral: Exercise
Supervised exercise sessions and independent exercise
Active Comparator: Mind-Body Group
Surgical preparation program
Behavioral: Surgical preparation program
Book, tapes, CD

Primary Outcome Measures :
  1. 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.

  2. Feasibility [ 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

Secondary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516190

Contact: Jennifer A Ligibel, MD 617-632-5943

United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Laura Shockro    617-632-5934   
Contact: Nancy Campbell    617-632-6779   
Principal Investigator: Jennifer A Ligibel, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Yale University
Susan G. Komen Breast Cancer Foundation
Principal Investigator: Jennifer A Ligibel, MD Dana-Farber Cancer Institute

Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT01516190     History of Changes
Other Study ID Numbers: 11-182
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: June 2016

Keywords provided by Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute:
stage I-III breast cancer