Clinical trial NCT01516190: The Preoperative Health & Body Study
Official title: The Preoperative Health & Body Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: stage I-III breast cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Yale University
name: Susan G. Komen Breast Cancer Foundation
First posted: 2012-01-24
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Impact of Exercise on Ki-67
timeFrame: 3 years
measure: Feasibility of intervention in women with newly diagnosed breast cancer
timeFrame: 3 years
Secondary outcomes:
measure: Impact of exercise on biomarkers
timeFrame: 3 years
measure: Impact of exercise on receptors
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer A Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.