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

NCT03833726 | Completed

• 1 other identifier: CAAP CA
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophy;Vaginal; Breast Cancer

Keywords

Vaginal Atrophy; Breast Cancer; Hormonal Therapy; Photodynamic Therapy; Light Emitting Diode

Outcome Measures

Primary Outcomes (2)

• Vaginal maturation index

  Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index

  Change from baseline at 3 months

• Female Sexual Function Index (FSFI) - Female Version (QS-F)

  Measure of quality of sex life. Full Scale Score Range 2-36

  Change from baseline at 3 months

Secondary Outcomes (8)

• Vaginal pH

  Change from baseline at 3 months

• Quality of life by FACT B

  Change from baseline at 3 months

• Urinary symptoms

  Change from baseline at 3 months

• Visual analog scale

  Change from baseline at 3 months

• Female Genital Self-Image Scale - 7 (FGSIS-7)

  Change from baseline at 3 months

Study Arms (2)

LED group

EXPERIMENTAL

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

Procedure: Experimental: LED group

Control group

SHAM COMPARATOR

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

Procedure: Sham Comparator: Control

Interventions

Experimental: LED group PROCEDURE

5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.

LED group

Sham Comparator: Control PROCEDURE

5 Sessions of 8 minute with device off and heated gel, 7 days apart.

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

Location

Related Publications (7)

• Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050.

  PMID: 25815692 BACKGROUND

• Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014 Jun;17(3):252-9. doi: 10.3109/13697137.2013.819327. Epub 2013 Aug 25.

  PMID: 23805799 BACKGROUND

• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19.

  PMID: 25179577 BACKGROUND

• Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.

  PMID: 7731384 BACKGROUND

• Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors:Treatments are available. Cleve Clin J Med. 2018 Oct;85(10):760-766. doi: 10.3949/ccjm.85a.17108.

  PMID: 30289755 BACKGROUND

• Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.

  PMID: 28154914 BACKGROUND

• Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016 Feb;84:75-80. doi: 10.1016/j.maturitas.2015.11.005. Epub 2015 Nov 12.

  PMID: 26617271 BACKGROUND

Related Links

• NCI Toxicity Scale

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Patríca V Lordelo, PhD

  Centro de Atenção Pélvica- CAAP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant will be randomly divided between LED group or LED Sham procedure that will consist of turned off device and heated gel and both patients and physiotherapists of kinesiotherapy phase wont be aware with group the participant is allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: February 7, 2019
• Study Start: January 30, 2019
• Primary Completion: April 20, 2023
• Study Completion: September 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

BR (1)