Laser Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Vaginal Fractional CO2 Laser Therapy can alleviate vaginal dryness in women who have survived breast cancer. Vaginal dryness often occurs after treatments like chemotherapy or medications such as tamoxifen. Participants will receive either the laser therapy or a placebo procedure to assess its effectiveness. Suitable candidates are women who have experienced bothersome vaginal dryness for at least three months and completed their main breast cancer treatment over a year ago. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
What prior data suggests that vaginal fractional CO2 laser therapy is safe for breast cancer survivors?
Research has shown that vaginal fractional CO2 laser therapy is generally safe for breast cancer survivors experiencing vaginal dryness. Studies have found that patients tolerate this treatment well, with no serious side effects reported. In one study, women noticed improvements in sexual function without major problems. Another study confirmed the safety of the laser treatment, but it was not more effective than a placebo. Overall, evidence suggests that while the treatment is safe, its effectiveness may vary.12345
Why do researchers think this study treatment might be promising for breast cancer survivors?
Researchers are excited about vaginal fractional CO2 laser therapy for breast cancer because it offers a non-invasive alternative to traditional treatments like surgery, chemotherapy, or radiation. Unlike these standard options, the laser therapy uses directed light energy to target specific tissues, potentially reducing side effects and preserving healthy tissue. Moreover, the therapy is quick, with sessions lasting only 20-30 minutes every six weeks, which could improve patient comfort and adherence. This innovative approach could significantly enhance the quality of life for patients by minimizing the physical and emotional toll typically associated with more aggressive treatments.
What evidence suggests that vaginal fractional CO2 laser therapy is effective for treating vaginal dryness in breast cancer survivors?
Research has shown that vaginal fractional CO2 laser therapy can alleviate vaginal dryness in breast cancer survivors. Some studies found that over 70% of patients reported satisfaction with their treatment and significant symptom improvement. However, other research suggests that while the treatment is safe, it may not outperform a placebo. In this trial, participants will receive either the vaginal fractional CO2 laser therapy or a placebo procedure at random. The treatment enhances elastin and collagen in the vaginal wall, supporting overall vaginal health. Although some findings are promising, results have been mixed, and further research is necessary for a clearer understanding.12678
Who Is on the Research Team?
Maryam Lustberg, MD, MPH
Principal Investigator
Yale University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo vaginal fractional CO2 laser therapy or placebo procedure every 6 weeks for 3 treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vaginal Fractional CO2 Laser Therapy
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Long-Term Follow-Up of Fractional CO2 Laser Therapy for ...
(4) Conclusions: Breast cancer survivors treated with fractional CO2 laser therapy have sustained improvement in sexual function two years after ...
Impact of fractional CO2 laser therapy on vaginal wall ... - PMC
Fractional CO2 vaginal laser therapy in BCSs produced a stromal response, with increased elastin and collagen III content and no epithelial changes. These ...
Microablative Fractional CO2 Laser for Vulvovaginal ...
In our pilot study, we found that more than 70% of the patient population was satisfied with the treatment. VVA symptoms and VHI improved significantly at 20 ...
Effect of Fractional Carbon Dioxide vs Sham Laser ...
These findings suggest that although vaginal laser treatment was safe, it was not more effective than first-line therapy with placebo treatment.
Microablative Fractional CO2 Laser for Vulvovaginal ...
Conclusion. A 20-week treatment with the fractional CO2 laser was efficacious and safe in inducing a significant improvement of VVA symptoms by ameliorating ...
Long-term efficacy of CO2 fractional laser in the treatment ...
The treatment was well tolerated, with no serious adverse events reported. For breast cancer survivors receiving adjuvant therapy, polynucleotide-based vaginal ...
Is Vaginal Laser Treatment Effective for Breast Cancer ...
Vaginal laser treatment was safe for women with a history of breast cancer, but it was no more effective than a fake laser treatment, ...
Efficacy of Erbium and CO2 Genital Laser Treatment on ... - PMC
Both CO 2 and erbium lasers appear to be safe and effective treatment options for breast cancer survivors with genitourinary syndrome.
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