GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.

Launched by UNIVERSITY HOSPITAL, GHENT · Sep 28, 2022

Keywords

ClinConnect Summary

The GRACE trial is a study that aims to explore how different local treatments can help women with vulvovaginal atrophy, a condition that causes discomfort such as dryness and irritation in the vaginal area. This trial specifically focuses on breast cancer patients who are currently receiving endocrine therapy, which is a common treatment for certain types of breast cancer. The goal is to find better ways to manage the symptoms of vulvovaginal atrophy, as many women with breast cancer have not received adequate care for this issue due to a lack of awareness and stigma surrounding it.

To participate in the trial, women need to be postmenopausal breast cancer patients currently undergoing endocrine therapy. They should have symptoms of vulvovaginal atrophy, such as pain during intercourse or vaginal dryness. Participants will be recruited from a specific age range and must not have had recent surgeries or use of certain medications. If you join the study, you can expect to receive one of the local treatments being tested and contribute to important research that may improve the quality of life for many women facing similar challenges.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • breast cancer patient
• • current endocrine therapy (AI or SERM)
• * postmenopausal status, defined by:
• • 12 months amenorrhoea or
• • 6 months amenorrhoe and FSH level of \>40 mIU/mL or
• • \*\>6 weeks after bilateral oophorectomy or
• • induced postmenopause (ovarian function suppression using GnRH-analogue)
• • presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation)
• Exclusion Criteria:
• • a history of vulvar or vaginal surgery (Inclusion is possible after hysterectomy. For these subjects no microbiome sampling will be performed. Microbiome analysis is not performed for these subjects.)
• • current other vulvar or vaginal disease
• • recent use of antibiotics/antifungals/corticosteroids (less than 1 month)
• • current use of vaginal hormonal treatment or vaginal moisturizer: inclusion is possible after a washout period of 4 weeks