An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy

An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy

Aino Fianu Jonasson,1 Mikael Åstrom2 1Department of Clinical Sciences, Intervention, and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute, Stockholm, Sweden; 2StatCons, Malmö, SwedenCorrespondence: Aino Fianu JonassonDepartment of Clinical Science, Intervention and Technology...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Jonasson AF, Åstrom M
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2021
Materias:
vulvo vaginal atrophy
mbs
non-hormonal therapy
dyspareunia
vaginal dryness
adjuvant ai therapy
breast cancer
Medical technology
R855-855.5
Acceso en línea:https://doaj.org/article/5a66ce6c9800426b892f310b8fb48547
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:5a66ce6c9800426b892f310b8fb48547
record_format dspace
spelling oai:doaj.org-article:5a66ce6c9800426b892f310b8fb485472021-12-02T17:45:21ZAn Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy1179-1470https://doaj.org/article/5a66ce6c9800426b892f310b8fb485472021-06-01T00:00:00Zhttps://www.dovepress.com/an-open-uncontrolled-pilot-study-on-12-week-use-of-vagivital-for-treat-peer-reviewed-fulltext-article-MDERhttps://doaj.org/toc/1179-1470Aino Fianu Jonasson,1 Mikael Åstrom2 1Department of Clinical Sciences, Intervention, and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute, Stockholm, Sweden; 2StatCons, Malmö, SwedenCorrespondence: Aino Fianu JonassonDepartment of Clinical Science, Intervention and Technology Division of Obstetrics and Gynecology, Karolinska Institute, Stockholm, 171 77, SwedenTel +46-70-483-6028Email aino.fianu.jonasson@ki.sePurpose: This pilot study assessed the efficacy of 12 weeks of daily treatment with a vaginal gel based on a water-based cellulose gel in reducing the severity of moderate–severe symptoms of vulvovaginal atrophy (VVA) and followed adverse events in female breast cancer patients undergoing treatment with adjuvant aromatase- inhibitor therapy.Methods: In this open, uncontrolled pilot study, the efficacy and safety of the gel during a treatment period of 12 weeks (daily 1× 1 mL) were evaluated (n=28). The gel is made of water and hypromellose, a hydropropylmetyl cellulose, which works by coating the vagina, and was developed to treat moderate–severe symptoms of VVA. The primary efficacy variable was the most bothersome symptom (MBS; among vulvovaginal irritation and itching, vaginal dryness, dysuria, or dyspareunia) self-identified at baseline on a four-point scale.Results: A total of 28 patients fulfilled all entry criteria and had data available after the start of treatment. Treatment with the gel reduced MBS scores from baseline (n=28, mean 2.71) to week 12 (n=27, mean 1.33, mean reduction 1.37; p=0), and reduced the overall total scores for VVA symptoms from a mean of 5.39 at baseline to 2.25 at week 12 (p=0). Eleven subjects (39%) reported 19 AEs.Conclusion: A 12-week treatment with the gel significantly reduced the severity of MBSs and VVA symptoms, improved quality of life, and was safe to use in women with breast cancer undergoing adjuvant aromatase-inhibitor therapy. In view of the beneficial effects of nonhormonal treatments, for cancer patients in particular, the water-based cellulose gel VagiVital is a suitable candidate for first-choice treatment of VVA symptoms in breast cancer patients and in women predisposed to cancer.Keywords: vulvovaginal atrophy, MBS, nonhormonal therapy, dyspareunia, vaginal dryness, adjuvant AI therapy, breast cancerJonasson AFÅstrom MDove Medical Pressarticlevulvo vaginal atrophymbsnon-hormonal therapydyspareuniavaginal drynessadjuvant ai therapybreast cancerMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 14, Pp 193-200 (2021)
institution DOAJ
collection DOAJ
language EN
topic vulvo vaginal atrophy
mbs
non-hormonal therapy
dyspareunia
vaginal dryness
adjuvant ai therapy
breast cancer
Medical technology
R855-855.5
spellingShingle vulvo vaginal atrophy
mbs
non-hormonal therapy
dyspareunia
vaginal dryness
adjuvant ai therapy
breast cancer
Medical technology
R855-855.5
Jonasson AF
Åstrom M
An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
description Aino Fianu Jonasson,1 Mikael Åstrom2 1Department of Clinical Sciences, Intervention, and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute, Stockholm, Sweden; 2StatCons, Malmö, SwedenCorrespondence: Aino Fianu JonassonDepartment of Clinical Science, Intervention and Technology Division of Obstetrics and Gynecology, Karolinska Institute, Stockholm, 171 77, SwedenTel +46-70-483-6028Email aino.fianu.jonasson@ki.sePurpose: This pilot study assessed the efficacy of 12 weeks of daily treatment with a vaginal gel based on a water-based cellulose gel in reducing the severity of moderate–severe symptoms of vulvovaginal atrophy (VVA) and followed adverse events in female breast cancer patients undergoing treatment with adjuvant aromatase- inhibitor therapy.Methods: In this open, uncontrolled pilot study, the efficacy and safety of the gel during a treatment period of 12 weeks (daily 1× 1 mL) were evaluated (n=28). The gel is made of water and hypromellose, a hydropropylmetyl cellulose, which works by coating the vagina, and was developed to treat moderate–severe symptoms of VVA. The primary efficacy variable was the most bothersome symptom (MBS; among vulvovaginal irritation and itching, vaginal dryness, dysuria, or dyspareunia) self-identified at baseline on a four-point scale.Results: A total of 28 patients fulfilled all entry criteria and had data available after the start of treatment. Treatment with the gel reduced MBS scores from baseline (n=28, mean 2.71) to week 12 (n=27, mean 1.33, mean reduction 1.37; p=0), and reduced the overall total scores for VVA symptoms from a mean of 5.39 at baseline to 2.25 at week 12 (p=0). Eleven subjects (39%) reported 19 AEs.Conclusion: A 12-week treatment with the gel significantly reduced the severity of MBSs and VVA symptoms, improved quality of life, and was safe to use in women with breast cancer undergoing adjuvant aromatase-inhibitor therapy. In view of the beneficial effects of nonhormonal treatments, for cancer patients in particular, the water-based cellulose gel VagiVital is a suitable candidate for first-choice treatment of VVA symptoms in breast cancer patients and in women predisposed to cancer.Keywords: vulvovaginal atrophy, MBS, nonhormonal therapy, dyspareunia, vaginal dryness, adjuvant AI therapy, breast cancer
format article
author Jonasson AF
Åstrom M
author_facet Jonasson AF
Åstrom M
author_sort Jonasson AF
title An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
title_short An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
title_full An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
title_fullStr An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
title_full_unstemmed An Open, Uncontrolled Pilot Study on 12-Week Use of VagiVital for Treatment of Vulvovaginal Atrophy in Breast Cancer Patients Undergoing Adjuvant Aromatase-Inhibitor Therapy
title_sort open, uncontrolled pilot study on 12-week use of vagivital for treatment of vulvovaginal atrophy in breast cancer patients undergoing adjuvant aromatase-inhibitor therapy
publisher Dove Medical Press
publishDate 2021
url https://doaj.org/article/5a66ce6c9800426b892f310b8fb48547
work_keys_str_mv AT jonassonaf anopenuncontrolledpilotstudyon12weekuseofvagivitalfortreatmentofvulvovaginalnbspatrophyinbreastcancerpatientsundergoingadjuvantaromataseinhibitortherapy
AT astromm anopenuncontrolledpilotstudyon12weekuseofvagivitalfortreatmentofvulvovaginalnbspatrophyinbreastcancerpatientsundergoingadjuvantaromataseinhibitortherapy
AT jonassonaf openuncontrolledpilotstudyon12weekuseofvagivitalfortreatmentofvulvovaginalnbspatrophyinbreastcancerpatientsundergoingadjuvantaromataseinhibitortherapy
AT astromm openuncontrolledpilotstudyon12weekuseofvagivitalfortreatmentofvulvovaginalnbspatrophyinbreastcancerpatientsundergoingadjuvantaromataseinhibitortherapy
_version_ 1718379588361388032

Ejemplares similares