Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment (LEDCA)

Centro de Atenção ao Assoalho Pélvico

Status: Completed

Conditions: Breast Cancer; Atrophy;Vaginal

Treatments: Procedure: Experimental: LED group; Procedure: Sham Comparator: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03833726

CAAP CA

Details and patient eligibility

About

Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.

Full description

The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functional changes in the vagina cutting in quality of life and impacting sexual function.

This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH <5.0 and vaginal cytology with predominance of superficial cells).

Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases.

Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions.

Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B).

At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction

Enrollment: 77 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-65 anos
• Pathological proven Breast Cancer diagnosis
• Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition
• Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa)
• Vaginal pH >5,0

Exclusion criteria

• Hormone replacement less than 6 months
• Diagnosis of vaginal infection
• Difficulty in understanding the proposed instruments
• Patients with chronic neurological degenerative diseases that preclude to be on position
• Metastatic disease
• Any vaginal photodynamic treatment less than 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups

LED group

Experimental group

Description:

Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy.

Treatment:

Procedure: Experimental: LED group

Control group

Sham Comparator group

Description:

Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy.

Treatment:

Procedure: Sham Comparator: Control