Breast Cancer and RehabilitationNCT07743294
Effect of Preoperative Rehabilitation Exercise on Improving Postoperative Lymphedema, Quality of Life and Care Needs in Patients With Breast Cancer Surgery
A study testing Preoperative Upper Limb Rehabilitation Exercise and Standard Nursing Care and Education in people with Breast Cancer and Rehabilitation, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Breast cancer is one of the most common cancers among women worldwide, with surgery being a primary treatment. However, surgical tumor resection combined with lymph node dissection often leads to upper extremity lymphedema as a complication. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer and Rehabilitation
- What is being tested?
- Preoperative Upper Limb Rehabilitation Exercise and Standard Nursing Care and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jun 2024to 31 Dec 2026
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with malignant breast cancer confirmed by post-surgical tissue examination.
- Receiving primary surgery, including tumor resection combined with axillary lymph node dissection.
- Age 20 years or older.
- Conscious, able to communicate in Mandarin or Taiwanese, aware of diagnosis, capable of completing questionnaires and participating in interventions, and signed informed consent.
Who cannot join
- Severe cognitive impairment or unaware of diagnosis, unable to complete questionnaires or correctly execute intervention measures.
- Patients in the control group who independently schedule outpatient rehabilitation after returning home.
- Unable to communicate in Mandarin or Taiwanese.
- Undergoing breast reconstruction surgery.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital Cancer Center
Taipei, 106
Meng-Ping Hsiao, +886-919865349, A00708@ntucc.gov.tw
Meng-Ping Hsiao
- Recruiting
National Taiwan University Hospital
Taipei
Meng-Ping Hsiao, +886-919865349, A00708@ntucc.gov.tw
About this study
Breast cancer is one of the most common cancers among women worldwide, with surgery being a primary treatment. However, surgical tumor resection combined with lymph node dissection often leads to upper extremity lymphedema as a complication. This study aims to evaluate the effectiveness of preoperative rehabilitation exercise on upper limb function, lymphedema severity, quality of life, and post-discharge care needs in breast cancer patients undergoing surgery.
Participants will be assigned to either an experimental group receiving individualized preoperative rehabilitation exercise instruction or a control group receiving standard clinical nursing education. Outcomes will be measured across seven time points from pre-operation up to one year post-surgery.
Read the detailed description
Background:
Surgical resection combined with axillary lymph node dissection in breast cancer patients frequently causes upper extremity lymphedema, negatively impacting physical function and quality of life. Implementing upper limb rehabilitation exercises prior to surgery may facilitate functional recovery and reduce postoperative complications.
Objectives:
- To evaluate the effect of preoperative upper limb rehabilitation exercise on reducing postoperative lymphedema in patients with breast cancer.
- To examine changes in quality of life and home care needs following preoperative rehabilitation intervention.
- To analyze factors influencing upper extremity function, lymphedema severity, quality of life, and care needs among breast cancer surgical patients.
Methods \& Procedures:
This longitudinal quasi-experimental study will recruit 105 patients scheduled for tumor resection with axillary lymph node dissection at National Taiwan University Hospital and National Taiwan University Hospital Cancer Center.
- Experimental Group: Receives individualized preoperative instruction and guidance on upper limb rehabilitation exercises starting preoperatively.
- Control Group: Receives routine clinical nursing education preoperatively or on postoperative Day 1 according to standard ward procedures.
Data Collection Timeline:
Data will be collected at seven time points:
- Pre-operation (1 week / 1 day prior to surgery)
- Postoperative Day 1
- Postoperative Week 2 (first clinic visit)
- Postoperative Week 4
- Postoperative Month 3
- Postoperative Month 6
- Postoperative Year 1
Assessment Parameters:
Measurements include arm circumference, handgrip strength, shoulder range of motion, functional activities of daily living (ADL), lymphedema-related symptoms, quality of life, and care needs. Descriptive statistics and Generalized Estimating Equations (GEE) will be used to analyze treatment outcomes over time.
- Conditions
- Breast Cancer and Rehabilitation
- Being tested
- Preoperative Upper Limb Rehabilitation Exercise, Standard Nursing Care and Education
- Keywords
- Lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Upper Limb Rehabilitation ExerciseBehavioural
Individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery to reduce postoperative lymphedema and improve physical function.
Standard Nursing Care and EducationOther
Routine clinical nursing education executed preoperatively or on postoperative Day 1 according to standard ward procedures.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Preoperative Exercise | Experimental | Participants in this group receive individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery. Receives: Behavioral: Preoperative Upper Limb Rehabilitation Exercise |
| Control Group: Standard Care | Active comparator | Participants in this group receive routine clinical nursing education preoperatively or on postoperative Day 1 according to standard ward procedures. Receives: Other: Standard Nursing Care and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)
Measured by changes in upper extremity arm circumference (in centimeters) at standardized anatomical points to evaluate lymphedema severity.
Measured: Baseline (1 day pre-operation), Postoperative Day 1, Week 2, Week 4, Month 3, Month 6, and Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer and RehabilitationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A non-randomized, two-group parallel design
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743294
- Sponsor's protocol ID
- 202405003RINB
- Other IDs
- NTUCCS-113-38
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 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 to protect participant privacy and maintain data confidentiality in accordance with institutional review board (IRB) guidelines and informed consent agreements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Rehabilitation Exercise on Improving Postoperative Lymphedema, Quality of Life and Care Needs in Patients With Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07743294
- Acronym / sponsor ID
- 202405003RINB
- Conditions
- Breast Cancer and Rehabilitation
- Keywords
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 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.
Breast cancer is one of the most common cancers among women worldwide, with surgery being a primary treatment. However, surgical tumor resection combined with lymph node dissection often leads to upper extremity lymphedema as a complication. This study aims to evaluate the effectiveness of preoperative rehabilitation exercise on upper limb function, lymphedema severity, quality of life, and post-discharge care needs in breast cancer patients undergoing surgery.
Participants will be assigned to either an experimental group receiving individualized preoperative rehabilitation exercise instruction or a control group receiving standard clinical nursing education. Outcomes will be measured across seven time points from pre-operation up to one year post-surgery.
Detailed description
Background:
Surgical resection combined with axillary lymph node dissection in breast cancer patients frequently causes upper extremity lymphedema, negatively impacting physical function and quality of life. Implementing upper limb rehabilitation exercises prior to surgery may facilitate functional recovery and reduce postoperative complications.
Objectives:
- To evaluate the effect of preoperative upper limb rehabilitation exercise on reducing postoperative lymphedema in patients with breast cancer.
- To examine changes in quality of life and home care needs following preoperative rehabilitation intervention.
- To analyze factors influencing upper extremity function, lymphedema severity, quality of life, and care needs among breast cancer surgical patients.
Methods \& Procedures:
This longitudinal quasi-experimental study will recruit 105 patients scheduled for tumor resection with axillary lymph node dissection at National Taiwan University Hospital and National Taiwan University Hospital Cancer Center.
- Experimental Group: Receives individualized preoperative instruction and guidance on upper limb rehabilitation exercises starting preoperatively.
- Control Group: Receives routine clinical nursing education preoperatively or on postoperative Day 1 according to standard ward procedures.
Data Collection Timeline:
Data will be collected at seven time points:
- Pre-operation (1 week / 1 day prior to surgery)
- Postoperative Day 1
- Postoperative Week 2 (first clinic visit)
- Postoperative Week 4
- Postoperative Month 3
- Postoperative Month 6
- Postoperative Year 1
Assessment Parameters:
Measurements include arm circumference, handgrip strength, shoulder range of motion, functional activities of daily living (ADL), lymphedema-related symptoms, quality of life, and care needs. Descriptive statistics and Generalized Estimating Equations (GEE) will be used to analyze treatment outcomes over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A non-randomized, two-group parallel design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Preoperative Exercise | Experimental | Behavioral: Preoperative Upper Limb Rehabilitation ExerciseParticipants in this group receive individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery. |
| Control Group: Standard Care | Active comparator | Other: Standard Nursing Care and EducationParticipants in this group receive routine clinical nursing education preoperatively or on postoperative Day 1 according to standard ward procedures. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with malignant breast cancer confirmed by post-surgical tissue examination.
- Receiving primary surgery, including tumor resection combined with axillary lymph node dissection.
- Age 20 years or older.
- Conscious, able to communicate in Mandarin or Taiwanese, aware of diagnosis, capable of completing questionnaires and participating in interventions, and signed informed consent.
Key exclusion criteria (4 listed)
- Severe cognitive impairment or unaware of diagnosis, unable to complete questionnaires or correctly execute intervention measures.
- Patients in the control group who independently schedule outpatient rehabilitation after returning home.
- Unable to communicate in Mandarin or Taiwanese.
- Undergoing breast reconstruction surgery.
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 |
|---|---|---|
| Preoperative Upper Limb Rehabilitation ExerciseIndividualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery to reduce postoperative lymphedema and improve physical function. | Behavioural | Experimental Group: Preoperative Exercise |
| Standard Nursing Care and EducationRoutine clinical nursing education executed preoperatively or on postoperative Day 1 according to standard ward procedures. | Other | Control Group: Standard Care |
Primary outcome
Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)
Time frame: Baseline (1 day pre-operation), Postoperative Day 1, Week 2, Week 4, Month 3, Month 6, and Year 1
Measured by changes in upper extremity arm circumference (in centimeters) at standardized anatomical points to evaluate lymphedema severity.
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 3 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and maintain data confidentiality in accordance with institutional review board (IRB) guidelines and informed consent agreements.
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Virtual Rehabilitation for Cancer Survivors
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Upper Limb Rehabilitation Exercise and Standard Nursing Care and Education in people with Breast Cancer and Rehabilitation, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 4 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 Meng-Ping Hsiao (+886-919865349, A00708@ntucc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Upper Extremity Lymphedema Severity (Arm Circumference) (time frame: Baseline (1 day pre-operation), Postoperative Day 1, Week 2, Week 4, Month 3, Month 6, and Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.