Actively Recruiting

Phase Not Applicable
FEMALE
Healthy Volunteers
ID06309290

Prehabilitation Based on Resistance-exercise Training in Women With Breast Cancer Undergoing Neoadjuvant Therapy: From Molecular Mechanism to Clinical Benefits

Led by Universidad de La Frontera · Updated on 2025-04-02

68

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Breast cancer is the leading cause of cancer-related deaths among women globally, with the highest incidence of any cancer. Treatment choices depend on cancer stage, subtype, and tumor size. Women with more aggressive types, such as HER2+ and Triple Negative breast cancer, often receive chemotherapy before surgery. These treatments can cause side effects like fatigue, reduced physical ability, and muscle loss, which can increase risks and lower quality of life. Early interventions to prevent muscle loss are important. This research evaluates prehabilitation using resistance-exercise training before surgery in women undergoing neoadjuvant chemotherapy for breast cancer. Participants are divided into two groups: one receives usual care, including diagnosis confirmation and chemotherapy planning, and the other group undergoes 16 to 20 weeks of full-body resistance training twice weekly along with usual care. Muscle mass and strength are measured before and after the training and four weeks post-surgery using CT scans and strength tests. Additional assessments include blood samples, physical performance tests, quality of life questionnaires, and muscle and tumor tissue sampling at surgery. Participants will be involved for about 20 weeks before surgery and followed for four weeks after surgery. They will attend exercise sessions if in the prehabilitation group and complete evaluations at baseline, after training, and post-surgery. Researchers measure changes in muscle mass, strength, physical function, fatigue, quality of life, clinical outcomes, and molecular markers. These findings aim to improve care strategies to reduce side effects and enhance recovery in breast cancer patients receiving chemotherapy before surgery.

CONDITIONS

Brief Title

Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women with stage I, II, or III breast cancer with luminal, HER2+, or triple negative tumors
  • Indicated for neoadjuvant chemotherapy
  • Candidates for curative breast surgery
  • Body mass index between 18.5 and 30 kg/m2
  • Sedentary lifestyle (less than two planned physical activities per week)
  • Willing to participate and follow the prehabilitation program
Not Eligible

You will not qualify if you...

  • Presence of conditions affecting muscle metabolism or mobility that prevent safe strength exercise (e.g., severe arthritis, neurological disorders, paralysis)
  • Severe or uncontrolled cardiovascular disease or cardiac ejection fraction less than 50%
  • Previous antineoplastic treatment
  • Use of nutritional supplements such as leucine, glutamine, casein, whey protein, fatty acids, or creatine

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Prehabilitation

Duration - 16 to 20 weeks

Participants in the prehabilitation group undergo 16 to 20 weeks of whole-body resistance-exercise training twice a week before surgery, while all participants receive neoadjuvant chemotherapy.

Twice weekly exercise sessions for 16 to 20 weeks

Surgery

Duration - 1 day

Participants undergo breast surgery after completing chemotherapy and prehabilitation or usual care.

1 visit (in-person) on the day of surgery

Post-surgery Follow-up

Duration - 4 weeks

Participants are assessed 4 weeks after surgery for muscle mass, strength, physical performance, clinical parameters, and quality of life.

1 follow-up visit 4 weeks after surgery

Trial Site Locations

Total: 2 locations

1

Fundación Arturo López Pérez

Santiago, Chile

Actively Recruiting

2

Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile

Temuco, Chile

Actively Recruiting

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Research Team

M

Macarena Artigas, PT, MSc

G

Gabriel N Marzuca-Nassr, PT, MSc, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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