Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Constriction, Pathologic

Pelvic Neoplasms

Quality of Life

The self-questionnaire of 104 questions collected personal and socio-demographics data, global and sexual quality of life characteristics (European Organisation for Research and Treatment of Cancer \[EORTC\] quality of life questionnaires: QLQ-C30 and gynecologic and cervical cancer specific-questionnaire QLQ-CX24), vaginal dilatators and moisturizers use, and barriers and facilitators of their use. Clinical data were extracted from the patients' medical files. Vaginal stenosis was evaluated at 6 weeks after the end of brachytherapy and after 1-year follow-up by in-town gynecologists or in our Institute, and censored in case of complete vaginal obliteration

Questionnaires

Christine KERR, MD

Gynecologic cancer treatments (chemoradiotherapy, brachytherapy and surgery) greatly impact patients' sexual quality of life (QoL). Use of the vaginal dilators may reduce vaginal stenosis. Since 2011, our "Gyn and Co LR" patient education program aims to optimize early care of sexual disorders following treatment of cervical and endometrial cancer.

Pelvic cancer accounts for 38,000 cancer cases in France; among them, 15,500 are gynecologic, i.e. endometrial, ovarian, cervical, vaginal and vulval. In 2017, 8,367 new endometrial cancer cases were reported in France1. Endometrial cancer mostly affects women who already underwent menopause; indeed, the median age at diagnosis is 68 years. Cervical cancer is less frequent, with 2,835 new cases reported in France in 2017, but affects younger women. The incidence peak is reported at 40 years, with a median age at death of around 50 years.

The standard of care for cervical cancer combines chemoradiotherapy with utero-vaginal brachytherapy, followed or not with surgery. For endometrial cancer, post-operative vaginal brachytherapy is recommended for intermediate-risk tumors or following radiotherapy for high-risk patients. However, in both cancer localizations, the combination of external radiation and brachytherapy induces numerous adverse effects affecting the patients' overall and sexual quality of life. Digestive, urinary and sexual disorders reported include abdominal pain, incontinence, cystitis, dyspareunia, vaginal irritation, pain during intercourse. A major adverse effect reported is reduction of vaginal elasticity together with vaginal shrinking (shorter and tighter vagina), up to vaginal stenosis. The EMBRACE study showed in 630 patients with locally-advanced cervical cancer a grade ≥ 2 vaginal stenosis rate of 21% at 2 years. A study reported that among sexually active women, 54% were not satisfied or little satisfied with their sexual activity; about 50% women also reported vaginal dryness and more than 40% pain during penetration. The EMBRACE study reported in locally-advanced cervical cancer patients the persistence of treatment-related symptoms, diarrhea, menopausal symptoms, peripheral neuropathy and sexual functioning problems two years after diagnosis. Vaginal dryness, hot flashes and pain at penetration were reported up to 5 to 10 years after diagnosis in cancer survivors as compared with controls in a case-control study. In endometrial cancer patients, a long-term analysis of the PORTEC-2 study reported vaginal dryness, short or narrow vagina and pain during intercourse at 7 years after treatment.

Studies in psycho-oncology or nursing care have assessed the impact of these disorders and are bringing up some solutions, among which use of vaginal dilators to prevent vaginal stenosis and improve sexual quality of life. International guidelines were issued on the use of vaginal dilators by these patients. Both guidelines and studies assessing patient education interventions to increase the patients' use of the vaginal dilators concluded on the possible benefit of educational programs stenosis prevention. Some programs well integrated in the patients' care pathway have been published. Early interventions starting as soon as the disease announcement consult with the radiation oncologist are still needed to improve vaginal stenosis prevention and the patients' sexual quality of life.

In this context, the investigator have initiated, for the first time in France, the "Gyn and Co LR" patient education program, approved by the Regional Health Agency. This program, fully integrated in the patients' care pathway, aimed to optimize an early care of sexual disorders and prevent vaginal stenosis in patients treated with brachytherapy for cervical or endometrial cancer.

Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

Vaginal Dilatators and Moisturizers Use and Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24

Clinical data from the patient medical file

Sexual quality of life questionnaire:EORTC QLQ-CX24

Institut du Cancer de Montpellier - Val d'Aurelle

Skin and Connective Tissue Diseases

Breast Neoplasms

Atrophy

Breast Diseases

Skin Diseases

Two applications of HA gel (Mucogyne®) per week during one year.

Laser CO2 for vulvovaginal area during 2 sessions (15 min) at visits D0 and M6.

Injection of 1 mL of HA at D0 and M6 (DESIRIAL®).

Vaginal gel based on HA with liposomal structure applicated 2 times a week

Hyaluronique Acid Gel

The laser energy delivered along the vaginal wall heats the tissue without damaging it.

Laser CO2

HA injection performed under the mucosae (2-3mm in depth) following one injection point every 5mm on the 3 first cm of the vagina and on the posterior part of the introitus.

Hyaluronique Acid Injection

Barbara HERSANT, MD

Yazid BELKACEMI, MD, PhD

YAZID BELKACEMI

Many studies have shown that locoregional treatment (surgery, radiotherapy) and systemic treatment (endocrine therapy and chemotherapy) for breast cancer (BC) may impact sexuality by causing physical and/or psychological damages.

Approximately 50-75 % of BC survivors suffer from vulvovaginal atrophy (VVA). The earliest symptoms of VVA are decreased vaginal lubrication, followed by other vaginal and urinary symptoms, such as burning, itching, bleeding, leucorrhoea, dyspareunia and dysuria symptoms. Various surveys have shown that VVA symptoms lead to female sexual disorder and on their partners through sexual unsatisfactory. However, it appears that sexuality is a little discussed topic during the follow-up of BC survivors. Most of patients relate a poor satisfaction with information and counselling related to sexuality and vaginal health, which are denied by many practitioners.

Patients treated for BC cannot find relief in hormonal replacement therapy (HRT), which is considered the gold standard treatment for VVA symptoms. The usual treatments for these women are topics such as ovula or gel (lubricant, hyaluronic acid (HA)...) with however, a short term effect even when these topics are applied regularly and correctly during at least 2 to 3/weeks.In the literature, there is a significant impact on VVA at one month but later data are lacking . Moreover, patients' compliance and daily application are paramount of importance for efficacy that could disappear when the treatment is stopped.

No randomized controlled trial has compared this treatment to innovative strategies. In this context, it is important to establish management strategies for VVA and sexual disorder after BC.

Our objective is to assess prevalence rate of VVA among breast cancer survivors after the loco regional treatment and chemotherapy, and to compare the efficacy of innovative treatments namely, new biophysical inductor (Laser CO2) and chemical bio inductor (Hyaluronic acid injections) treatments to the efficacy of standard non-hormonal topic treatment for improving the VVA and the quality of sexual life on a long-term.

An open-label multicentre controlled trial randomized in 3 parallel groups (1:1:1) to assess the one-year superiority of bio physical inductor (C02 laser, D0 and M6, group laser) compared to the standard treatment currently recommended (Mucogyne, 2 times a week for one year, control group) in the one hand, and of chemical bio inductor (Desirial, injection of 1 mL of hyaluronic acid in the first 3 cm of the vaginal walls, D0 and M6, HA injection group) compared to the control group in the other hand in BC survivors with VVA, with blinded primary endpoint assessment.

The use of these innovative treatments (lasers and injections) for Vulvovaginal atrophy based on the bio induction and the regenerative medicine could improve the quality of the vaginal mucosa after breast cancer therapy and could be a new strategy for these women who cannot benefit from Hormone Replacement Therapy (HRT). The benefits expected are the improvement of the quality of vulvo-vaginal mucosa and the improvement of the sexual quality of life of the patient.

An open-label multicentre controlled trial randomized in 3 parallel groups (1:1:1) :

* Bio physical inductor : CO2 laser
* Standard treatment : Hyaluronic Acid gel
* Chemical bio inductor : injection of Hyaluronic Acid

According to the center's organization, an operator and an investigator-evaluator will be identified for each patient or for all patients.

Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment

Prospective Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment : a Randomized Multicenter Controlled Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.	NCT04184154	Pelvic Cancer Cervical Cancer	Questionnaires	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Evaluation of Innovative Therapeutic Approaches of Vaginal and Sexual Dysfunction After Breast Cancer Treatment	NCT04713917	Breast Cancer	Hyaluronique Ac... Laser CO2 Hyaluronique Ac...	18 Years - 75 Years	Assistance Publique - Hôpitaux de Paris
Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.	NCT04184154	Pelvic Cancer Cervical Cancer	Questionnaires	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for sexual quality of life