Preoperative Health & Body for Breast Cancer

(PreHab Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Tamoxifen, Raloxifene, Aromatase inhibitors

Disqualifiers: Other malignancy, Metastatic disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

49 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for English-speaking women with newly diagnosed stage I-III breast cancer, who are fit enough to exercise and can participate in the study for at least 3 weeks before surgery. They must not be receiving neoadjuvant therapy, have metastatic disease, or a recent history of other cancers except certain skin or cervical cancers.

Inclusion Criteria

I am scheduled for surgery to remove breast cancer within 8 weeks.

I can speak and read English.

I am fully active or can carry out light work.

Exclusion Criteria

I am scheduled for initial treatment before my main cancer treatment.

My cancer has spread to other parts of my body.

My breast cancer cannot be removed with initial surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants engage in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery

3-6 weeks

Multiple sessions (in-person and independent)

Follow-up

Participants are monitored for changes in stress, anxiety, mood, quality of life, and biomarkers

3 years

Treatment Details

Interventions

• Exercise
• Surgical preparation program

Trial Overview The study examines if short-term exercise or Mind-Body programs before breast surgery can improve stress, mood, quality of life and affect cancer cell markers. Women will be randomly assigned to these preoperative health interventions.

Participant Groups

Group I: Exercise Group Active Control 1 Intervention

Supervised exercise sessions and independent exercise

Group II: Mind-Body Group Active Control 1 Intervention

Surgical preparation program

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials

68

Recruited

220,000+