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NCT Number: NCT07425379

Prehabilitation in Breast Cancer Surgery

This prospective, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety/depression, and lymphedema incidence up to 2 years postoperatively.

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Key information

Conditions

Breast Cancer (Early Breast Cancer) Breast Diseases Breast Neoplasms Cancer Rehabilitation Lymphedema Arm Neoplasms Neoplasms by Site Postoperative Shoulder Dysfunction Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sadi Konuk Bakirkoy Training and Health Hospital

Istanbul, 34140, Turkey (Türkiye)

Location contact

Demet Ferahman

CONTACT

[email protected]

05364702930

About this study

Breast cancer surgery is associated with postoperative morbidity including shoulder dysfunction, pain, fatigue, and lymphedema. Prehabilitation aims to optimize functional capacity before surgery and may reduce postoperative complications.

This single-center randomized controlled trial will enroll 54 women with stage I-III invasive breast cancer scheduled for mastectomy or breast-conserving surgery. Participants will be randomized to:

  • Home-based structured prehabilitation program
  • Usual preoperative care

Primary endpoints are shoulder range of motion (goniometric measurement) and DASH score changes across multiple time points. Participants will be followed for up to 24 months for lymphedema development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women aged 18-80

Stage I-III invasive breast cancer

Scheduled for surgery

≥3 weeks before surgery

No neoadjuvant therapy

Exclusion criteria

Exercise contraindication

Active shoulder pathology

Severe cardiopulmonary disease

Planned neoadjuvant therapy

Treatment and study plan

Home-Based Prehabilitation Exercise Program

Other

Participants assigned to this arm will receive a structured, home-based prehabilitation program initiated at least three weeks prior to surgery. The intervention includes: (1) moderate-intensity aerobic exercise (3 sessions per week, 30 minutes per session, target intensity RPE 4-6/10), (2) upper extremity resistance exercises using elastic bands (3 sessions per week, 3 sets of 10 repetitions per exercise), and (3) mobility and stretching exercises focused on shoulder function.

The program will be delivered through written materials and instructional exercise videos accessible via QR code. Participants will receive elastic resistance bands for training. Adherence and progression will be monitored weekly via remote follow-up (telephone or email contact). The intervention is non-pharmacological and designed to optimize upper extremity function prior to breast cancer surgery.

Usual Care

Other

Usual Preoperative Care

Primary outcomes

  1. Change in Shoulder Range of Motion (degrees)

    Time frame: Baseline to 12 weeks post-op

    Measured by goniometer

  2. DASH Score

    Time frame: Baseline to 12 weeks post-op

    Change in DASH Score The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item patient-reported outcome measure assessing upper extremity disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status.

Secondary outcomes

  1. Grip Strength

    Time frame: Baseline to 12 weeks post-op

    Grip Strength in kgs

  2. Pain (Brief Pain Inventory - BPI)

    Time frame: baseline to 12 weeks

    Pain severity and pain-related interference will be assessed using the Brief Pain Inventory (BPI). The BPI evaluates pain intensity (0-10 numeric rating scale) and its impact on daily functioning. Higher scores indicate greater pain severity and interference.

  3. Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)

    Time frame: 0-12 months

    Cancer-related fatigue will be measured using the FACT-F questionnaire. The scale consists of 13 items scored from 0 to 4, with total scores ranging from 0 to 52. Lower scores indicate greater fatigue severity.

  4. Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)

    Time frame: baseline to 12 weeks

    Functional disability will be assessed using the 12-item interviewer-administered WHODAS 2.0. Total scores range from 0 to 48, with higher scores indicating greater disability and functional impairment.

  5. Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)

    Time frame: baseline to 12 weeks

    Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), consisting of 14 items divided into anxiety (HADS-A) and depression (HADS-D) subscales. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity.

  6. Lymphedema Incidence

    Time frame: baseline to 2 years postop

    Upper extremity lymphedema will be assessed using circumferential limb measurements at standardized anatomical points. Lymphedema will be defined as a ≥2 cm inter-limb difference or ≥10% volume difference compared to the contralateral arm, confirmed by clinical evaluation. Outcome will be reported as incidence (yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Demet Ferahman, MD

CONTACT

[email protected]

+905364702930

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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