Breast Cancer FemalesNCT07378319
Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.
A study testing ultrasound guided dextrose prolotherapy in people with Breast Cancer Females, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- ultrasound guided dextrose prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2025to 28 Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of breast cancer surgery (mastectomy or breast-conserving surgery), with or without axillary lymph node dissection
- Persistent ipsilateral chest wall and/or axillary pain, tightness, or movement restriction lasting ≥ 3 months after surgery;
- Clinically significant baseline symptom severity, defined as Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ≥ 25 and/or pain intensity ≥ 5/10 on the Numeric Rating Scale (NRS);
- Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to completion of therapy below the minimal clinically important difference (MCID; <15 points ) and/or pain improvement < 2 points on the NRS .
- Age ≥ 18 years;
- Ability to provide written informed consent.
Who cannot join
- Evidence of local cancer recurrence or metastatic disease;
- Active lymphedema requiring ongoing decongestive therapy at the time of enrollment;
- Shoulder pathology, including intra-articular or peri-articular conditions (e.g., adhesive capsulitis with marked capsular restriction, or acute rotator cuff tear,) judged by clinical assessment to be the dominant cause of symptoms.
- Active infection, skin lesion, or unhealed surgical wound at the intended injection site;
- Known bleeding disorders or anticoagulant use contraindicating injection;
- Known allergy to dextrose or any components of the injection protocol;
- Pregnancy or other medical conditions precluding participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans Genetal Hospital
Taichung, Taiwan, 407
Yuchun Lee, M.D., 886423592525 ext. 3507, lyczoj@vghtc.gov.tw
About this study
Official title: Effectiveness of Ultrasound-Guided Dextrose Prolotherapy for Persistent Chest Wall and Axillary Symptoms in Breast Cancer Survivors: A Prospective Case Series.
The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard physical therapy.
The main questions it aims to answer are:
Read more
Does ultrasound-guided dextrose prolotherapy significantly improve upper extremity functional limitation (measured by the QuickDASH questionnaire)?
What are the effects of this intervention on pain intensity (NRS), active shoulder range of motion (AROM), and anterior chest wall soft-tissue tightness (pectoralis minor muscle length)?
Participants will:
Undergo a comprehensive baseline physical examination and ultrasound assessment of the symptomatic chest wall and axilla.
Receive three sessions of ultrasound-guided 5% dextrose injections into targeted soft-tissue planes at 4-week intervals.
Continue their designated standard rehabilitation program, including range-of-motion and stretching exercises.
Attend follow-up assessments at 4-week intervals during the treatment phase, with long-term follow-up at 3 and 6 months after the final injection to evaluate the durability of the response.
Read the detailed description
Detailed Description Post-surgical breast cancer survivors often experience persistent shoulder and upper-quarter dysfunction characterized by chest wall and axillary tightness. While conventional physical therapy focuses on joint mobilization and stretching, a subset of patients with significant soft-tissue fibrosis and scar adhesions-patterns reflecting extra-articular restriction-remains non-responsive to standard care.
This prospective case series evaluates the role of ultrasound-guided dextrose prolotherapy as a targeted intervention for this challenging clinical problem. The rationale is based on the mechanical and biological effects of dextrose-based hydrodissection, which aims to separate adherent fascial planes and promote tissue remodeling in areas of postoperative myofascial restriction.
Procedural Workflow:
Scanning Protocol: A high-frequency linear transducer is used to systematically scan the ipsilateral pectoral and axillary regions. The physician identifies symptomatic areas characterized by tissue thickening, loss of normal fascial glide, or focal tenderness.
Injection Technique: Using a sterile, ultrasound-guided approach, a dextrose solution is administered into the identified myofascial or perimysial planes. The injection targets are individualized based on each participant's specific site of restriction (e.g., between the pectoralis major and minor muscles or within the axillary fascia).
Frequency and Duration: Participants receive a total of three injection sessions spaced 4 weeks apart. This interval allows for the observation of cumulative clinical effects and soft-tissue adaptation.
Integrated Care: To maximize functional gains, all participants continue a standardized, home-based rehabilitation program consisting of progressive stretching and postural correction throughout the 6-month study period.
The study aims to provide preliminary data on whether this interventional approach can bridge the therapeutic gap for survivors with persistent myofascial symptoms despite prior rehabilitation.
- Conditions
- Breast Cancer Females
- Being tested
- ultrasound guided dextrose prolotherapy
- Keywords
- breast cancer, dextrose injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided dextrose prolotherapyProcedure or surgery
Participants receive three sessions of ultrasound-guided 5% dextrose injections into symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axillary region. The technique involves identifying areas of soft-tissue thickening or restricted fascial glide under high-frequency ultrasound. Injection targets are individualized to each patient's specific site of restriction (e.g., clavipectoral fascia, pectoralis major-minor interface, or axillary fascia). Sessions are administered at 4-week intervals (at weeks 0, 4, and 8).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this single experimental arm will receive three sessions of ultrasound-guided dextrose injections (e.g., 5% or 15% Dextrose) targeting symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axilla, such as the pectoralis major-minor interface or axillary fascia. Injections are administered at 4-week intervals (at Baseline, Week 4, and Week 8). Throughout the 6-month study period, all participants continue their standardized rehabilitation program, which includes range-of-motion exercises, stretching of the chest wall and axillary musculature, and progressive strengthening. Receives: Procedure: ultrasound guided dextrose prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Function
Upper extremity functional limitation was assessed using the QuickDASH questionnaire, with scores ranging from 0 (no disability) to 100 (most severe disability). The minimal clinically important difference (MCID) for the QuickDASH was defined as 15 points
Measured: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
Secondary outcomes (3)
Pain Intensity
Pain intensity was measured using the Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Participants were instructed to rate their pain intensity during provoked overhead activity or movements that most reliably reproduced their symptoms. A change of ≥ 2 points on the NRS was considered clinically meaningful
Measured: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
Shoulder Range of Motion
Active shoulder range of motion (AROM) was measured using a standard goniometer, including forward flexion and abduction, the most consistently assessed directions across prior studies
Measured: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
Pectoralis Minor Length
Anterior chest wall soft-tissue tightness was assessed by measuring pectoralis minor muscle length. Specifically, the linear distance between the coracoid process and the anterior inferior edge of the fourth rib was measured in the supine position
Measured: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection , and 6 months after the 3rd injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start11 Jan 2025
- Primary completion1 Feb 2026
- Study completion28 Jun 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 FemalesStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study utilizes a prospective, single-arm, interventional model (Single Group Assignment) designed as a pilot case series. The design focuses on evaluating the within-subject changes in functional and pain-related outcomes following a standardized interventional protocol.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuchun Lee, M.D., Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378319
- Sponsor's protocol ID
- VGHTHU114122
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-Guided Dextrose Prolotherapy for Persistent Chest Wall and Axillary Symptoms in Breast Cancer Survivors: A Prospective Case Series.
- ClinicalTrials.gov ID
- NCT07378319
- Acronym / sponsor ID
- VGHTHU114122
- Conditions
- Breast Cancer Females
- Keywords
- breast cancer, dextrose injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 11 Jan 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 30 Jan 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.
The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard physical therapy.
The main questions it aims to answer are:
Does ultrasound-guided dextrose prolotherapy significantly improve upper extremity functional limitation (measured by the QuickDASH questionnaire)?
What are the effects of this intervention on pain intensity (NRS), active shoulder range of motion (AROM), and anterior chest wall soft-tissue tightness (pectoralis minor muscle length)?
Participants will:
Undergo a comprehensive baseline physical examination and ultrasound assessment of the symptomatic chest wall and axilla.
Receive three sessions of ultrasound-guided 5% dextrose injections into targeted soft-tissue planes at 4-week intervals.
Continue their designated standard rehabilitation program, including range-of-motion and stretching exercises.
Attend follow-up assessments at 4-week intervals during the treatment phase, with long-term follow-up at 3 and 6 months after the final injection to evaluate the durability of the response.
Detailed description
Detailed Description Post-surgical breast cancer survivors often experience persistent shoulder and upper-quarter dysfunction characterized by chest wall and axillary tightness. While conventional physical therapy focuses on joint mobilization and stretching, a subset of patients with significant soft-tissue fibrosis and scar adhesions-patterns reflecting extra-articular restriction-remains non-responsive to standard care.
This prospective case series evaluates the role of ultrasound-guided dextrose prolotherapy as a targeted intervention for this challenging clinical problem. The rationale is based on the mechanical and biological effects of dextrose-based hydrodissection, which aims to separate adherent fascial planes and promote tissue remodeling in areas of postoperative myofascial restriction.
Procedural Workflow:
Scanning Protocol: A high-frequency linear transducer is used to systematically scan the ipsilateral pectoral and axillary regions. The physician identifies symptomatic areas characterized by tissue thickening, loss of normal fascial glide, or focal tenderness.
Injection Technique: Using a sterile, ultrasound-guided approach, a dextrose solution is administered into the identified myofascial or perimysial planes. The injection targets are individualized based on each participant's specific site of restriction (e.g., between the pectoralis major and minor muscles or within the axillary fascia).
Frequency and Duration: Participants receive a total of three injection sessions spaced 4 weeks apart. This interval allows for the observation of cumulative clinical effects and soft-tissue adaptation.
Integrated Care: To maximize functional gains, all participants continue a standardized, home-based rehabilitation program consisting of progressive stretching and postural correction throughout the 6-month study period.
The study aims to provide preliminary data on whether this interventional approach can bridge the therapeutic gap for survivors with persistent myofascial symptoms despite prior rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilizes a prospective, single-arm, interventional model (Single Group Assignment) designed as a pilot case series. The design focuses on evaluating the within-subject changes in functional and pain-related outcomes following a standardized interventional protocol.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: ultrasound guided dextrose prolotherapyParticipants in this single experimental arm will receive three sessions of ultrasound-guided dextrose injections (e.g., 5% or 15% Dextrose) targeting symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axilla, such as the pectoralis major-minor interface or axillary fascia. Injections are administered at 4-week intervals (at Baseline, Week 4, and Week 8). Throughout the 6-month study period, all participants continue their standardized rehabilitation program, which includes range-of-motion exercises, stretching of the chest wall and axillary musculature, and progressive strengthening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of breast cancer surgery (mastectomy or breast-conserving surgery), with or without axillary lymph node dissection
- Persistent ipsilateral chest wall and/or axillary pain, tightness, or movement restriction lasting ≥ 3 months after surgery;
- Clinically significant baseline symptom severity, defined as Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ≥ 25 and/or pain intensity ≥ 5/10 on the Numeric Rating Scale (NRS);
- Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to completion of therapy below the minimal clinically important difference (MCID; <15 points ) and/or pain improvement < 2 points on the NRS .
- Age ≥ 18 years;
Key exclusion criteria (7 listed)
- Evidence of local cancer recurrence or metastatic disease;
- Active lymphedema requiring ongoing decongestive therapy at the time of enrollment;
- Shoulder pathology, including intra-articular or peri-articular conditions (e.g., adhesive capsulitis with marked capsular restriction, or acute rotator cuff tear,) judged by clinical assessment to be the dominant cause of symptoms.
- Active infection, skin lesion, or unhealed surgical wound at the intended injection site;
- Known bleeding disorders or anticoagulant use contraindicating injection;
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 |
|---|---|---|
| ultrasound guided dextrose prolotherapyParticipants receive three sessions of ultrasound-guided 5% dextrose injections into symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axillary region. The technique involves identifying areas of soft-tissue thickening or restricted fascial glide under high-frequency ultrasound. Injection targets are individualized to each patient's specific site of restriction (e.g., clavipectoral fascia, pectoralis major-minor interface, or axillary fascia). Sessions are administered at 4-week intervals (at weeks 0, 4, and 8). | Procedure or surgery | Experimental Group |
Primary outcome
Upper Extremity Function
Time frame: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
Upper extremity functional limitation was assessed using the QuickDASH questionnaire, with scores ranging from 0 (no disability) to 100 (most severe disability). The minimal clinically important difference (MCID) for the QuickDASH was defined as 15 points
3 secondary outcomes
Pain Intensity
Time frame: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
Shoulder Range of Motion
Time frame: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection
Pectoralis Minor Length
Time frame: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection , and 6 months after the 3rd injection
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 20 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available upon reasonable request.
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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.
Yuchun Lee, M.D. principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided dextrose prolotherapy in people with Breast Cancer Females, run by Taichung Veterans General Hospital at 1 site 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 6 inclusion and 7 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 20 Mar 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 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 Yuchun Lee, M.D. (886423592525 ext. 3507, lyczoj@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Function (time frame: Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection). 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 20 Mar 2026.