Product involved: Mucosamin Vaginal Cream
Women treated with Vaginal Brachytherapy after surgery
Study:
Mucosamin® vaginal cream in women treated with VBT (Vaginal Brachytherapy) after surgery in prevention of vaginal mucositis.
Design:
Total: 120 women divided in 2 groups:
- Group A – treatment with Mucosamin® vaginal (2 applications per day for 1 month);
- Group B – no treatment.
Measurements:
Evaluation for subjective parameters, included the adverse events as per CTCAE 4.03 scale, at time 0, 3 months and 1 year after treatment.
POST TREATMENT VAGINAL INFLAMMATION (3 MONTHS)
POST TREATMENT VAGINAL PAIN (3 MONTHS)
Light mucositis: grade G0 and G1; Severe Mucositis: grade G2 and G3
Post treatment vaginal dryness (1 year)
Post treatment Vaginal Stricture (1 year)
Light mucositis: grade G0 and G1; Severe Mucositis: grade G2 and G3
Clinical Results
• Application of Mucosamin® vaginal cream during VBT was shown to have clinical benefit for FIGO* stage I endometrial cancer patients who received adjuvant HDR-VBT following surgery.
• It appears to reduce the severity of mucosal reactions.
• Optimal resolution of actinic vaginitis symptoms.
*FIGO – International Federation of Gynecology and Obstetrics
