The Preoperative Health & Body Study

Breast Cancer Clinical Trial

— PreHab  

Official title:

The Preoperative Health & Body Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01516190
• Other study ID #: 11-182
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: September 2024
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Exercise
Supervised exercise sessions and independent exercise
• Surgical preparation program
Book, tapes, CD

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Susan G. Komen Breast Cancer Foundation, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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