NCT07425379

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

February 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 15, 2026

Last Update Submit

February 23, 2026

Conditions

Breast Cancer (Early Breast Cancer)Postoperative Shoulder DysfunctionLymphedema ArmCancer Rehabilitation

Keywords

PrehabilitationBreast Cancer SurgeryShoulder Range of MotionUpper Extremity FunctionCancer RehabilitationExercise Therapy

Outcome Measures

Primary Outcomes (2)

  • Change in Shoulder Range of Motion (degrees)

    Measured by goniometer

    Baseline to 12 weeks post-op

  • DASH Score

    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.

    Baseline to 12 weeks post-op

Secondary Outcomes (6)

  • Grip Strength

    Baseline to 12 weeks post-op

  • Pain (Brief Pain Inventory - BPI)

    baseline to 12 weeks

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

    0-12 months

  • Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)

    baseline to 12 weeks

  • Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)

    baseline to 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Prehabilitation Group

EXPERIMENTAL

Participants will receive a structured home-based prehabilitation program delivered through written materials and instructional exercise videos (QR code access). The program includes: Aerobic training (3/week, 30-40 minutes, RPE 4-6) Upper extremity resistance exercises (3 days/week, 3 sets of 10 repetitions) Mobility and stretching exercises Adherence will be monitored through weekly remote follow-up (telephone)

Other: Home-Based Prehabilitation Exercise Program

Usual Care

ACTIVE COMPARATOR

Standard preoperative counseling without structured exercise prescription.

Other: Usual Care

Interventions

Home-Based Prehabilitation Exercise ProgramOTHER

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.

Prehabilitation Group
Usual CareOTHER

Usual Preoperative Care

Usual Care

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is limited to female participants because breast cancer surgery in this protocol focuses on women with stage I-III invasive breast cancer. Although breast cancer can occur in men, male patients represent a small proportion of cases and may have different clinical and surgical characteristics. Restricting enrollment to women ensures a more homogeneous study population and improves internal validity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18-80
  • Stage I-III invasive breast cancer
  • Scheduled for surgery
  • ≥3 weeks before surgery
  • No neoadjuvant therapy

You may not qualify if:

  • Exercise contraindication
  • Active shoulder pathology
  • Severe cardiopulmonary disease
  • Planned neoadjuvant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sadi Konuk Bakirkoy Training and Health Hospital

Istanbul, Istanbul, 34140, Turkey (Türkiye)

Location

Related Publications (1)

  • Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.

    PMID: 33072603BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Demet Ferahman, MD

CONTACT

+905364702930demetferahman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a single-center, prospective, two-arm, parallel-group randomized controlled trial. Participants will be randomized in a 1:1 ratio using a computer-generated block randomization scheme with variable block sizes. Randomization will be stratified by surgical type (mastectomy vs. breast-conserving surgery) and age group. The intervention group will receive a structured home-based prehabilitation program prior to surgery, while the control group will receive usual preoperative care. Outcome assessors will be blinded to group allocation. All analyses will be conducted according to the intention-to-treat principle.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional data protection policies and local regulations governing patient privacy. De-identified data may be available upon reasonable request and subject to ethics committee approval.

Locations

TU(1)