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New treatment option for Breast Cancer Females
Official title Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.
ClinicalTrials.gov ID: NCT07378319
What this study is testing
- What it's testing
- 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)?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to...
- Age ≥ 18 years;
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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...
- Age ≥ 18 years;
- Ability to provide written informed consent.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taichung, Taiwan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taichung, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.