The Preoperative Health & Body Study

NCT01516190 | Active Not Recruiting DMC

• 1 other identifier: 11-182
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage I-III breast cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  3 years

• 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

  3 years

Secondary Outcomes (2)

• Impact of exercise on biomarkers

  3 years

• Impact of exercise on receptors

  3 years

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

Supervised exercise sessions and independent exercise

Behavioral: Exercise

Mind-Body Group

ACTIVE COMPARATOR

Surgical preparation program

Behavioral: Surgical preparation program

Interventions

Exercise BEHAVIORAL

Supervised exercise sessions and independent exercise

Exercise Group

Surgical preparation program BEHAVIORAL

Book, tapes, CD

Mind-Body Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Yale University: collaborator
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 34648061 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer A Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2015
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)