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The Preoperative Health & Body Study (PreHab)

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Surgical preparation program
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I-III breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Exercise Group

Mind-Body Group

Arm Description

Supervised exercise sessions and independent exercise

Surgical preparation program

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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)
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.

Full Information

First Posted
January 19, 2012
Last Updated
October 16, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Yale University, Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01516190
Brief Title
The Preoperative Health & Body Study
Acronym
PreHab
Official Title
The Preoperative Health & Body Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2011 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Yale University, Susan G. Komen Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I-III breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Supervised exercise sessions and independent exercise
Arm Title
Mind-Body Group
Arm Type
Active Comparator
Arm Description
Surgical preparation program
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Supervised exercise sessions and independent exercise
Intervention Type
Behavioral
Intervention Name(s)
Surgical preparation program
Intervention Description
Book, tapes, CD
Primary Outcome Measure Information:
Title
Impact of Exercise on Ki-67
Description
To explore the impact of exercise upon Ki-67, a tissue-based biomarker associated with breast cancer risk and progression.
Time Frame
3 years
Title
Feasibility of intervention in women with newly diagnosed breast cancer
Description
To evaluate the feasibility of conducting a window of opportunity study utilizing exercise and mind-body intervention in women with newly diagnosed breast cancer
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Impact of exercise on biomarkers
Description
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)
Time Frame
3 years
Title
Impact of exercise on receptors
Description
To explore the impact of a 3-6 week exercise intervention upon expression of metabolic, sex steroid and related receptors in malignant breast tissue.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34648061
Citation
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.
Results Reference
derived

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The Preoperative Health & Body Study

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