Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01516190

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Supervised exercise sessions and independent exercise

Surgical preparation program

Behavioral

Book, tapes, CD

Primary outcomes

  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 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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation
  • Yale University

Registry information

Acronym: PreHab

Important dates

Study start
2011
Primary completion
2015
Study completion
2026
First posted
Jan 24, 2012
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.