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

NCT05562518 | Active Not Recruiting Phase 4

• 1 other identifier: BC-09638
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Vulvovaginal Atrophy

Keywords

breast cancer; vulvovaginal atrophy; endocrine therapy

Outcome Measures

Primary Outcomes (3)

• Change in symptoms and quality of life after implementation of treatment in a time frame of 12 weeks using the EQ5D-questionnaire.

  Efficacy of the implemented treatments will be assessed based on patient-reported outcome measurements (PROM) that describe symptoms and quality-of-life. The first primary outcome will be based on assessment using the EQ5D-questionnaire. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). The change in these PROMs will be evaluated over the predefined timeframe of 12 weeks. The EQ5D-questionnaire includes a scale describing the general health of the participant at the predefined times, using a metric scale from 0 to 100 (0 being the worst health and 100 being the best health).

  12 weeks

• Change in symptoms and quality of life after implementation of treatment in a time frame of 12 weeks using the FACT-ES questionnaire.

  Efficacy of the implemented treatments will be assessed based on patient-reported outcome measurements (PROM) that describe symptoms and quality-of-life. The second primary outcome will be based on assessment using the FACT-ES-questionnaire. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). The change in these PROMs will be evaluated over the predefined timeframe of 12 weeks. The FACT-ES consists of question with answer possibilities from 0 to 4 (with the higher the score, the better the quality of life).

  12 weeks

• Change in sex steroid hormone concentrations in a time frame of 12 weeks.

  The change in concentration of sex steroid hormone concentration as a surrogate for safety be be evaluated by measuring the sex hormone concentrations systemically with repeated longitudinal measurements. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). The following sex steroid hormone concentrations will be assessed: estrone, estradiol, DHEA-S, DHEA, testosterone, and dihydrotestosterone.

  12 weeks

Secondary Outcomes (1)

• Identification of vaginal microbial alterations after implementation of treatment.

  12 weeks

Study Arms (4)

Estrogen

ACTIVE COMPARATOR

locally administered estrogen (oestriol)

Drug: Estrogen

Dehydroepiandrosterone

ACTIVE COMPARATOR

locally administered dehydroepiandrosterone (DHEA)

Drug: dehydroepiandrosterone

Estrogen + probiotics

ACTIVE COMPARATOR

locally administered estrogen (oestriol) + probiotics

Drug: Estrogen + probiotics

Moisturizer

ACTIVE COMPARATOR

locally administered hyaluronic acid

Drug: Moisturizer

Interventions

Estrogen DRUG

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

Estrogen

dehydroepiandrosterone DRUG

1 vaginal ovule daily

Dehydroepiandrosterone

Estrogen + probiotics DRUG

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

Estrogen + probiotics

Moisturizer DRUG

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

Moisturizer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer patient
• current endocrine therapy (AI or SERM)
• postmenopausal status, defined by:
• months amenorrhoea or
• 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)

You may not qualify if:

• current other vulvar or vaginal disease
• recent use of antibiotics/antifungals/corticosteroids (less than 1 month)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estrogens; Dehydroepiandrosterone; Probiotics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hans Verstraelen, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: September 30, 2022
• Study Start: March 21, 2022
• Primary Completion: March 2, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

BE (1)