Breast Cancer (Early Breast Cancer)NCT07425379
Prehabilitation in Breast Cancer Surgery
A study testing Home-Based Prehabilitation Exercise Program in people with Breast Cancer (Early Breast Cancer) and Postoperative Shoulder Dysfunction, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer (Early Breast Cancer), Postoperative Shoulder Dysfunction, Lymphedema Arm
- What is being tested?
- Home-Based Prehabilitation Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-80
- Stage I-III invasive breast cancer
- Scheduled for surgery
- ≥3 weeks before surgery
- No neoadjuvant therapy
Who cannot join
- Exercise contraindication
- Active shoulder pathology
- Severe cardiopulmonary disease
- Planned neoadjuvant therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Dr. Sadi Konuk Bakirkoy Training and Health Hospital
Istanbul, Istanbul, 34140
Demet Ferahman, 05364702930, demetferahman@gmail.com
About this study
Official title: Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development
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.
Read the detailed description
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.
- Conditions
- Breast Cancer (Early Breast Cancer), Postoperative Shoulder Dysfunction, Lymphedema Arm, Cancer Rehabilitation
- Being tested
- Home-Based Prehabilitation Exercise Program, Usual Care
- Keywords
- Prehabilitation, Breast Cancer Surgery, Shoulder Range of Motion, Upper Extremity Function, Cancer Rehabilitation, Exercise Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual CareOther
Usual Preoperative Care
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Home-Based Prehabilitation Exercise Program |
| Usual Care | Active comparator | Standard preoperative counseling without structured exercise prescription. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Range of Motion (degrees)
Measured by goniometer
Measured: 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.
Measured: Baseline to 12 weeks post-op
Secondary outcomes (6)
Grip Strength
Grip Strength in kgs
Measured: Baseline to 12 weeks post-op
Pain (Brief Pain Inventory - BPI)
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.
Measured: baseline to 12 weeks
Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)
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.
Measured: 0-12 months
Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
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.
Measured: baseline to 12 weeks
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
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.
Measured: baseline to 12 weeks
Lymphedema Incidence
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).
Measured: baseline to 2 years postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer (Early Breast Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Demet Ferahman, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425379
- Sponsor's protocol ID
- Dr. Sadi Konuk Bakirkoy
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33072603
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development
- ClinicalTrials.gov ID
- NCT07425379
- Acronym / sponsor ID
- Dr. Sadi Konuk Bakirkoy
- Conditions
- Breast Cancer (Early Breast Cancer), Postoperative Shoulder Dysfunction, Lymphedema Arm, Cancer Rehabilitation
- Keywords
- Prehabilitation, Breast Cancer Surgery, Shoulder Range of Motion, Upper Extremity Function, Cancer Rehabilitation, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Group | Experimental | Other: Home-Based Prehabilitation Exercise ProgramParticipants 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) |
| Usual Care | Active comparator | Other: Usual CareStandard preoperative counseling without structured exercise prescription. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18-80
- Stage I-III invasive breast cancer
- Scheduled for surgery
- ≥3 weeks before surgery
- No neoadjuvant therapy
Key exclusion criteria (4 listed)
- Exercise contraindication
- Active shoulder pathology
- Severe cardiopulmonary disease
- Planned neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Prehabilitation Exercise ProgramParticipants 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. | Other | Prehabilitation Group |
| Usual CareUsual Preoperative Care | Other | Usual Care |
Primary outcome
Change in Shoulder Range of Motion (degrees)
Time frame: Baseline to 12 weeks post-op
Measured by goniometer
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.
6 secondary outcomes
Grip Strength
Time frame: Baseline to 12 weeks post-op
Pain (Brief Pain Inventory - BPI)
Time frame: baseline to 12 weeks
Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)
Time frame: 0-12 months
Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
Time frame: baseline to 12 weeks
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
Time frame: baseline to 12 weeks
Lymphedema Incidence
Time frame: baseline to 2 years postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 33072603Brahmbhatt 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Prehabilitation Exercise Program in people with Breast Cancer (Early Breast Cancer) and Postoperative Shoulder Dysfunction, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demet Ferahman, MD (+905364702930, demetferahman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Range of Motion (degrees) (time frame: Baseline to 12 weeks post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.