Shockwave Therapy for Fibrosis of the Breast

Overseen By Antoinette Nguyen

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Cardiac pacemakers, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Pulsed Acoustic Cellular Expression therapy for fibrosis of the breast?

Research on extracorporeal shock wave therapy, a similar treatment, shows it can reduce pain and soften fibrotic tissue in breast implant cases, suggesting potential benefits for breast fibrosis. ^{1 2 3 4 5}

Is shockwave therapy generally safe for humans?

Research on shockwave therapy, including its use for gene delivery and cancer treatment, suggests it can be safe when used with optimal parameters to minimize cell damage. Studies have shown that low-energy shock waves can be a safe method for gene delivery and improving blood flow in certain conditions, indicating a potential for safe application in humans. ^{6 7 8 9 10}

How is Shockwave Therapy for Fibrosis of the Breast different from other treatments?

Shockwave Therapy for Fibrosis of the Breast is unique because it uses sound waves to temporarily change cell membrane permeability, allowing for non-invasive delivery of therapeutic molecules directly into cells. This method avoids the need for more invasive procedures and can potentially enhance the effectiveness of gene therapy without damaging the cells. ^{6 7 9 11 12}

What is the purpose of this trial?

This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.

Eligibility Criteria

This trial is for adults over 18 who've had plastic surgery and now have firmness in the tissue, suggesting fibrosis. It's not for those with pacemakers, conditions that could risk their safety or affect results, or if they can't follow the visit schedule. Fibrosis next to bone or in face/neck areas also disqualifies.

Inclusion Criteria

I have had plastic surgery and now have firmness in the tissue, suggesting scarring.

I am over 18 years old.

Exclusion Criteria

Subjects with cardiac pacemakers

Other medical or psychiatric condition that may increase the risk associated with study participation, may complicate subject compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

Patients who, in the opinion of the investigator, would not be compliant with the schedule of study visits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

Treatment Details

Interventions

• Pulsed Acoustic Cellular Expression therapy

Trial Overview The study is testing Pulsed Acoustic Cellular Expression therapy (extracorporeal shockwave therapy) to see if it can reduce fibrosis—stiffness and scarring—in soft tissues after surgery.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The intervention arm receives eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2

Group II: Control Active Control 1 Intervention

The control arm receives eight sessions of a sham (placebo) version of the therapy.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Extracorporeal shock wave treatment of capsular fibrosis after mammary augmentation - Preliminary results. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Relationship between DNA double-strand breaks, cell killing, and fibrosis studied in confluent skin fibroblasts derived from breast cancer patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Advanced co-culture 3D breast cancer model for investigation of fibrosis induced by external stimuli: optimization study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Multiple extracorporeal shock wave therapy degrades capsular fibrosis after insertion of silicone implants. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Prophylactic use of external ultrasound for breast implant capsular contracture. [2016]

6. England pubmed.ncbi.nlm.nih.gov

The Application of Clinical Lithotripter Shock Waves to RNA Nucleotide Delivery to Cells. [2017]

7. Greece pubmed.ncbi.nlm.nih.gov

High energy shock waves (HESW) for sonodynamic therapy: effects on HT-29 human colon cancer cells. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of acoustic shock waves on clonogenic growth and drug sensitivity of human tumor cells in vitro. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Novel mechanism of gene transfection by low-energy shock wave. [2018]

10. Japan pubmed.ncbi.nlm.nih.gov

Low-energy extracorporeal shock wave therapy improves microcirculation blood flow of ischemic limbs in patients with peripheral arterial disease: pilot study. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Shock wave application to cell cultures. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Shock wave-induced permeabilization of mammalian cells. [2018]