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The Preoperative Health & Body Study (PreHab)

This study is currently recruiting participants.
Verified June 2016 by Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516190
First Posted: January 24, 2012
Last Update Posted: June 2, 2016
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.
Collaborators:
Yale University
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
January 19, 2012
January 24, 2012
June 2, 2016
August 2011
April 2017   (Final data collection date for primary outcome measure)
  • 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 [ 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
Same as current
Complete list of historical versions of study NCT01516190 on ClinicalTrials.gov Archive Site
  • 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)
  • 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.
Same as current
Not Provided
Not Provided
 
The Preoperative Health & Body Study
The Preoperative Health & Body 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Breast Cancer
  • Behavioral: Exercise
    Supervised exercise sessions and independent exercise
  • Behavioral: Surgical preparation program
    Book, tapes, CD
  • Active Comparator: Exercise Group
    Supervised exercise sessions and independent exercise
    Intervention: Behavioral: Exercise
  • Active Comparator: Mind-Body Group
    Surgical preparation program
    Intervention: Behavioral: Surgical preparation program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
September 2017
April 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Jennifer A Ligibel, MD 617-632-5943 jennifer_ligibel@dfci.harvard.edu
United States
 
 
NCT01516190
11-182
Yes
Not Provided
Not Provided
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Yale University
  • Susan G. Komen Breast Cancer Foundation
Principal Investigator: Jennifer A Ligibel, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP