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Trial Title:
GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.
NCT ID:
NCT05562518
Condition:
Vulvovaginal Atrophy
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Atrophy
Estrogens
Dehydroepiandrosterone
Conditions: Keywords:
breast cancer
vulvovaginal atrophy
endocrine therapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Estrogen
Description:
1 vaginal ovule daily for three consecutive weeks, followed by 1 vaginal ovule 2 times
per week
Arm group label:
Estrogen
Intervention type:
Drug
Intervention name:
dehydroepiandrosterone
Description:
1 vaginal ovule daily
Arm group label:
Dehydroepiandrosterone
Intervention type:
Drug
Intervention name:
Estrogen + probiotics
Description:
2 vaginal ovules daily for 5 consecutive days, repeated every 4 weeks
Arm group label:
Estrogen + probiotics
Intervention type:
Drug
Intervention name:
Moisturizer
Description:
1 vaginal ovule daily for 10 consecutive days, followed by 1 vaginal ovule every three
days
Arm group label:
Moisturizer
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.
Detailed description:
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.
While current knowledge on comparative data of the local treatments of vulvovaginal
atrophy is based on retrospective data or one-to-one comparisons, we will prospectively
evaluate all different local treatments based on patient-reported outcome measurements.
This new data is mandatory for increasing the awareness of physicians of the treatment
possibilities of vulvovaginal atrophy in breast cancer patients. Together with the use of
different communication channels towards patients, this combination will substantially
contribute to the increase of quality-of-life of breast cancer patients with vulvovaginal
atrophy.
The primary objectives in this trial are two-fold. The first primary objective addresses
the efficacy of the different implemented treatment strategies based on patient-reported
outcome measurements (PROMs). These PROMs will be implemented prior to treatment and
after initiation of the implemented treatments (estrogen, DHEA, probiotics or
moisturizer). By implementing repeated PROM assessment, longitudinal evaluation of
symptom alterations due to the treatment can be objectified.
The second primary objective is the safety evaluation of the implemented treatments. This
evaluation will be achieved by measuring the sex hormone concentrations systemically with
repeated longitudinal measurements.
In this study, the investigators will measure sex hormone concentrations through
high-sensitive assessments based on LC-MS/MS. Considering the ALARA (as low a reasonably
achievable) principle in radiation safety, we could extrapolate this ALARA principle to
the safety of the local hormonal treatment of vulvovaginal atrophy in breast cancer
patients, where potential differences in increase of sex hormone concentrations between
the different treatment modalities could be objectified. Despite previous literature that
could not show increased recurrence of breast cancer, this finding will play an import
role in the decision-making of treatment of vulvovaginal atrophy in breast cancer
patients. As mentioned earlier, a direct comparison of these sex hormone concentrations
for the different treatment modalities is currently lacking.
As translational secondary objective, the investigators aim to investigate the microbial
alterations when using local treatment for vulvovaginal atrophy. Identification of these
alterations will contribute in understanding the pathophysiology of vulvovaginal atrophy
and may unravel changes caused by the local treatment and may create opportunities in the
future for additive treatment or new therapeutic strategies to ameliorate the
quality-of-life of breast cancer patients with vulvovaginal atrophy.
Criteria for 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
- 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Ghent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Hans Verstraelen
Email:
hans.verstraelen@uzgent.be
Contact backup:
Last name:
Glenn Vergauwen
Email:
glenn.vergauwen@uzgent.be
Start date:
March 21, 2022
Completion date:
March 1, 2027
Lead sponsor:
Agency:
University Hospital, Ghent
Agency class:
Other
Collaborator:
Agency:
University Ghent
Agency class:
Other
Source:
University Hospital, Ghent
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05562518
