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The Preoperative Health & Body Study (PreHab)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Yale University
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01516190
First received: January 19, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention
Breast Cancer
Behavioral: Exercise
Behavioral: Surgical preparation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Preoperative Health & Body Study

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Impact of Exercise on Ki-67 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To explore the impact of exercise upon Ki-67, a tissue-based biomarker associated with breast cancer risk and progression.

  • Feasibility [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • Impact of exercise on biomarkers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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)

  • Impact of exercise on receptors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To explore the impact of a 3-6 week exercise intervention upon expression of metabolic, sex steroid and related receptors in malignant breast tissue.


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516190

Contacts
Contact: Jennifer A Ligibel, MD 617-632-5943 jennifer_ligibel@dfci.harvard.edu

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Laura Shockro    617-632-5934    lshockro@partners.org   
Contact: Nancy Campbell    617-632-6779    ncampbell1@partners.org   
Principal Investigator: Jennifer A Ligibel, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Yale University
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Jennifer A Ligibel, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01516190     History of Changes
Other Study ID Numbers: 11-182
Study First Received: January 19, 2012
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
stage I-III breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014