Using CO2 laser therapy to treat menopause symptoms in cancer survivors
The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
This study is testing if CO2 laser therapy can help women who survived cancer feel better from menopause symptoms when other treatments aren't safe for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | Female |
| Sponsor | Lumenis Be Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06318052 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of fractional CO2 laser therapy in alleviating Genitourinary Syndrome of Menopause (GSM) symptoms in women who have survived cancer. Given that conventional hormonal treatments are often contraindicated for this population, the study aims to provide a non-hormonal alternative. Participants will be randomly assigned to receive either CO2 laser treatment or a non-hormonal gel treatment, with the goal of assessing safety and efficacy. The study focuses on improving the quality of life for cancer survivors experiencing GSM symptoms.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 to 70 who have completed cancer treatment at least 6 months prior and are experiencing severe GSM symptoms.
Not a fit: Patients with metastatic cancer or those currently undergoing active cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for cancer survivors suffering from GSM symptoms.
How similar studies have performed: Preliminary evidence suggests that laser treatments for GSM symptoms are safe and effective, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who have had non-metastatic (M0, ≤Stage IIIA) cancer with any hormone receptor and her2 neu status who have completed cancer-related treatment\>=6 months prior to enrollment with no evidence of metastasis or currently active disease * Women currently on endocrine therapy, single agent Herceptin, or observation * Patient-reported dyspareunia and/or vaginal dryness with the severity of \>=4 on a scale from 0 (none) to 10 (most severe) that has been persistent for over \>= 4 weeks and/or the inability to be sexually active due to pain * Age 21 to 70 years * Subjects seeking treatment of GSM * Objective evidence of menopause: percentage of superficial vaginal epithelial cells of vaginal smear (MI) ≤ 5% and Vaginal fluid pH \> 4.5 (for women within the first 3 years post-menopause) * Normal Papanicolaou (PAP) test smear last performed as a standard of care * Negative urine analysis * Sexually active (having sexual intercourse at least once a month) or desire to maintain sexual activity * Informed consent process completed and subject signed a consent form. * Able and willing to comply with the treatment/follow-up schedule and requirements * Patient is willing to use non-hormonal contraception method during the course of the study. Exclusion Criteria: * Active genital infection. * Acute or (recurring) Urinary Tract Infection (UTI) or genital infection (e.g. Herpes or candida or (condyloma ) defined as \> 2 episodes in the recent year. * Hormonal replacement therapies (local or systemic) within the last 6 weeks. * Pelvic Organ Prolapse (POP ≥ 2) according to the pelvic organ prolapse quantification system (may be relative). * Prior reconstructive pelvic mesh surgery. * Previous surgery in the treated area in the last 6 months. * Participation in a study of another device or drug within 6 months prior to enrollment or during this study, if treatments of the vagina were involved. * Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety. * Patient is pregnant or planning to become pregnant within the next six months.
Where this trial is running
Hamburg
- Frauenarztpraxis Heussweg — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Matthias Theden-Schow, Dr — Central study center
- Study coordinator: Charlotte Sachs
- Email: csachs98@googlemail.com
- Phone: 4210613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.