RecruitingPhase 4NCT05562518

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


Sponsor

University Hospital, Ghent

Enrollment

160 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatments for vaginal dryness, itching, and pain during sex in breast cancer survivors who are taking hormone-blocking therapy (endocrine therapy). These symptoms — called vaginal or vulvar atrophy — are common side effects of anti-estrogen treatments. The study tests whether one treatment works better than the other without affecting breast cancer outcomes. **You may be eligible if...** - You have been diagnosed with breast cancer - You are currently on endocrine therapy (an aromatase inhibitor or SERM) - You are postmenopausal (no period for 12 months, or other confirmed criteria) - You have one or more symptoms of vaginal dryness, painful intercourse, or irritation **You may NOT be eligible if...** - You have had prior vaginal or vulvar surgery (hysterectomy is allowed) - You currently have another vaginal or vulvar disease - You used antibiotics, antifungals, or corticosteroids in the past month - You are currently using vaginal hormones or moisturizers (you may be eligible after a 4-week washout period) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEstrogen

1 vaginal ovule daily for three consecutive weeks, followed by 1 vaginal ovule 2 times per week

DRUGdehydroepiandrosterone

1 vaginal ovule daily

DRUGEstrogen + probiotics

1 vaginal ovule daily for 12 consecutive days, followed by 1 vaginal ovule 2 times per week

DRUGMoisturizer

1 vaginal ovule daily for 14 consecutive days, followed by 1 vaginal ovule every three days


Locations(1)

University Hospital Ghent

Ghent, Belgium

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NCT05562518


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