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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if short exercise or Mind-Body programs can improve well-being for women between a breast cancer diagnosis and surgery. Researchers are examining changes in stress, anxiety, mood, and quality of life, along with potential effects on breast cancer cells and blood hormones linked to cancer. Women recently diagnosed with stage I-III breast cancer and planning surgery within the next 8 weeks may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance well-being during a challenging time.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking tamoxifen, raloxifene, or an aromatase inhibitor at the time of breast cancer diagnosis.

What prior data suggests that these programs are safe for participants?

Research has shown that exercise programs before surgery are generally safe and well-tolerated. A review found that following exercise guidelines for cancer patients is safe and can aid recovery. Another study demonstrated that better fitness before surgery can lead to fewer complications afterward. Thus, exercising before surgery appears to be a safe choice for most people.

The Mind-Body program is part of surgical preparation. Research indicates that preparing both physically and mentally can aid recovery. This dual approach is safe and might improve postoperative well-being.

Overall, both exercise and Mind-Body programs have been shown to be safe and could benefit those preparing for breast cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these approaches because they focus on holistic, non-pharmacological strategies to improve outcomes for breast cancer patients undergoing surgery. Unlike traditional treatments that mainly involve chemotherapy, radiation, and surgery, the exercise program provides both supervised and independent exercise sessions to enhance physical fitness and possibly improve recovery. The surgical preparation program, or mind-body group, aims to prepare patients mentally and physically for surgery, which could reduce stress and improve surgical outcomes. These methods emphasize patient empowerment and overall well-being, offering a fresh angle in the management of breast cancer.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare the effects of two different preoperative interventions for breast cancer patients: an Exercise Group and a Mind-Body Group. Research has shown that exercise, which participants in the Exercise Group will engage in, can greatly enhance the quality of life and physical abilities of breast cancer patients. Studies have found that exercise is linked to lower chances of breast cancer recurrence and reduced death rates. Additionally, women who stay active have a lower risk of developing breast cancer, with some studies suggesting a 20% lower risk.

Meanwhile, the Mind-Body Group will participate in a surgical preparation program. Evidence from similar programs suggests they can improve the quality of life for breast cancer patients. These programs are practical and can help women prepare both mentally and physically for surgery. While the effect on cancer markers is still under investigation, these programs are seen as beneficial for overall well-being. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Ligibel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11184867/

Effectiveness of exercise modalities on breast cancer ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

2. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325007152

Effect of physical exercise on the quality of life of women ... Women surviving breast cancer (WSBC) may experience reduced quality of life (QoL) due to disease-associated manifestations and undergone treatment.

4. aacrjournals.org aacrjournals.org/clincancerres/article/25/17/5398/81644/Impact-of-a-Pre-Operative-Exercise-Intervention-on

Impact of a Pre-Operative Exercise Intervention on Breast ... Observational studies have demonstrated that physically active women are at lower risk of developing breast cancer, with most studies suggesting a 20% reduction ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2819794

Early Implementation of Exercise to Facilitate Recovery ... Findings In this randomized clinical trial, significantly more participants in the exercise group regained 95% of their shoulder strength after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10923032/

Prescribing pre‐ and post‐operative physical activity ... This systematic review aimed to examine existing qualitative evidence focusing on pre‐ and post‐operative physical activity interventions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7544900/

Feasibility of Prehabilitation Prior to Breast Cancer Surgery Higher levels of preoperative aerobic fitness are associated with better surgical outcomes including decreased postoperative complications and mortality in ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960740413000182

A systematic review of pre-surgical exercise intervention ... Research into the correlation between pre-surgical exercise and the adverse effects of surgery could offer cancer survivors a better quality of recovery.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842824000623

Physical activity for cancer prehabilitation: A scoping review This scoping review aims to synthesize the current landscape of physical activity in cancer prehabilitation and identify knowledge gaps.

10. nature.com nature.com/articles/s41416-024-02748-x

The Physical Activity and Cancer Control (PACC) framework The 2019 ACSM updated exercise guidelines for cancer survivors stated that exercise training was generally safe and well tolerated during and ...