The Preoperative Health & Body Study

Study Overview
=================
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.

Official Title
-----------------
The Preoperative Health & Body Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Surgical preparation program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Group<br>Supervised exercise sessions and independent exercise | Behavioral: Exercise<br>* Supervised exercise sessions and independent exercise<br>|
| Active Comparator: Mind-Body Group<br>Surgical preparation program | Behavioral: Surgical preparation program<br>* Book, tapes, CD<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 years | 
| 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. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I-III breast cancer