Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Maneno muhimu
Kikemikali
Maelezo
LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero)
Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.
Tarehe
| Imethibitishwa Mwisho: | 02/29/2020 |
| Iliyowasilishwa Kwanza: | 07/31/2018 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 08/12/2018 |
| Iliyotumwa Kwanza: | 08/13/2018 |
| Sasisho la Mwisho Liliwasilishwa: | 03/09/2020 |
| Sasisho la Mwisho Lilichapishwa: | 03/11/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 07/23/2018 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 06/30/2020 |
| Tarehe ya Kukamilisha Utafiti: | 09/30/2021 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: CO2 Fractional Ablative Laser
Device: Placebo
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: CO2 Fractional Ablative Laser 3 treatments approximately 4 weeks apart with vaginal/vulval laser | Device: CO2 Fractional Ablative Laser Vaginal / vulval laser treatment |
| Placebo Comparator: Placebo 3 treatments approximately 4 weeks apart with "sham" laser | Device: Placebo Sham Device |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | Female |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Women with a history of early breast cancer >18 years of age - At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia. - Three groups of patients will qualify: - Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for >6 months - Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor - Postmenopausal women on tamoxifen or an aromatase inhibitor - Willingness to give written informed consent and willingness to comply with the study - Up to date pap test / HPV (human papillomavirus) testing Exclusion Criteria: - Medical contraindication to the use of fractional ablative CO2 laser - Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment - Use of vaginal lubricants or moisturisers 14 days prior to the study treatment - Active or recent genitourinary infections (<30 days) - Genital prolapse (grade III) - Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts) - Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus) |
Matokeo
Hatua za Matokeo ya Msingi
1. Vaginal dryness [12 weeks after completion of treatment]
Hatua za Matokeo ya Sekondari
1. Other symptoms of vulvovaginal atrophy [12 weeks after completion of treatment and 12 months after active treatment]
2. Maturation index [12 weeks after completion of treatment and 12 months after active treatment]
3. Vaginal pH [12 weeks after completion of treatment and 12 months after active treatment]
4. Clinician Assessed Changes [12 weeks after completion of treatment and 12 months after active treatment]
5. Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index [12 weeks after completion of treatment and 12 months after active treatment]
6. Sexual Function [12 weeks after completion of treatment and 12 months after active treatment]
7. Satisfaction with treatment assessed on a Likert Scale [12 weeks after completion of treatment and 12 months after active treatment]
8. Safety of laser treatment (Side effects) [15 months]
