Evaluation of the Impact of Multidisciplinary Oncosexology Management Associated With Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer

Breast Cancer Clinical Trial

— EVABIOSEIN  

Official title:

Evaluation of the Impact of Multidisciplinary Oncosexology Management Associated With Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer - EVABIOSEIN

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347926
• Other study ID #: PROICM 2023-11 EVA
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Angélique Bobrie, MD
• Phone: 467618576
• Email: angelique.bobrie[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge.

Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France.

Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. A study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment.

Description:

Breast cancer affects around one in eight women, accounting for 58,459 new cases in 2018 in France. Advances in treatment have improved overall survival, which is currently around 90% at 5 years in industrialized countries. In France, 5.3% of women have survived breast cancer.

However, the disease and its treatment are responsible for symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with the specific problems of the post-cancer period, and care for them has become a major health issue, highlighted in international recommendations and in Cancer Plans since 2003.

Sexual health is a crucial component of well-being and overall quality of life. Sexual quality of life is frequently impaired after cancer treatment. A large-scale survey carried out in France showed that sexual quality of life remained impaired in almost two thirds of patients 2 years and 5 years after cancer diagnosis, all sites combined. An abundance of literature underlines the high frequency of sexuality and intimacy disorders in patients treated for breast cancer, from diagnosis, throughout treatment and into the post-cancer period.

Sexual health is a complex issue, influenced by multiple factors such as education, beliefs, socio-cultural factors, intimacy, relationship with partner, physical and psychological well-being, body image, and personal and gender identity. These multiple factors can be disrupted, modified and altered as a result of cancer diagnosis and treatment. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors.

However, the management of sexual disorders remains underdeveloped in France. Three prospective studies have been carried out at the Institute of Cancer in Montpellier (ICM), two of which have been published, analyzing sexual quality of life in patients with non-metastatic breast cancer, and have shown a deterioration in sexual quality of life similar to that described in the literature, with in particular a high frequency of libido disorders, vaginal dryness and altered sexual satisfaction. A low level of communication between patients and healthcare professionals was reported, with a high demand for care expressed by patients. Patients' opinions and suggestions for optimal care were also collected and analyzed. The analysis of these data showed that patients had initiated first-line treatments for vaginal dryness.

Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. Light Emitting Diode (LED) PBM has been proposed as an alternative treatment for genitourinary menopausal syndrome. he tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. This non-invasive technique has few contraindications (epilepsy, photosensitizing treatment) and no known serious side effects, and has been studied in a number of indications, notably for the treatment of oral mucositis. There are few data on vaginal application, and this technology is being evaluated as part of a clinical trial at the Nimes hospital in patients with GSM in the general population. Interim results based on the inclusion of 130 patients showed clinical improvement in 61 out of 100 patients ("better" or "much better") treated with 6 sessions of PBM, with no serious adverse effects (PhD thesis). There are currently no data specifically on women treated for breast cancer. In the context of setting up an oncosexology care network at the Institute of Cancer in Montpellier, a study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Woman = 18,

2. Diagnosis of breast cancer regardless of tumor biology or stage (localized or metastatic),

3. Patient with persistent menopause genito-urinary symptoms after a minimum of 3 months of local treatment with vaginal moisturizers.

Exclusion Criteria:

1. Patient who have already undergone or are undergoing a 2nd-line treatment for menopause genito-urinary symptoms (photobiomodulation, laser, intra-vaginal injection of hyaluronic acid, etc.),

2. Patient with psychic or cognitive impairment, or not sufficiently fluent in French to be able to fill in the quality of life questionnaires.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Photobiomodulation
One session per week for six weeks

Locations

Country	Name	City	State
France	Institute of Cancer in Montpellier	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (14)

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Ben Charif A, Bouhnik AD, Courbiere B, Rey D, Preau M, Bendiane MK, Peretti-Watel P, Mancini J. Sexual health problems in French cancer survivors 2 years after diagnosis-the national VICAN survey. J Cancer Surviv. 2016 Jun;10(3):600-9. doi: 10.1007/s11764-015-0506-3. Epub 2015 Dec 21. — View Citation

Bobrie A, Jarlier M, Moussion A, Jacot W, D'Hondt V. Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures. Support Care Cancer. 2022 Apr;30(4):3633-3641. doi: 10.1007/s00520-022-06810-3. Epub 2022 Jan 14. — View Citation

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Del Pup L, Villa P, Amar ID, Bottoni C, Scambia G. Approach to sexual dysfunction in women with cancer. Int J Gynecol Cancer. 2019 Mar;29(3):630-634. doi: 10.1136/ijgc-2018-000096. Epub 2019 Feb 13. — View Citation

Dizon DS. Quality of life after breast cancer: survivorship and sexuality. Breast J. 2009 Sep-Oct;15(5):500-4. doi: 10.1111/j.1524-4741.2009.00766.x. Epub 2009 Jul 14. — View Citation

Frechette D, Paquet L, Verma S, Clemons M, Wheatley-Price P, Gertler SZ, Song X, Graham N, Dent S. The impact of endocrine therapy on sexual dysfunction in postmenopausal women with early stage breast cancer: encouraging results from a prospective study. Breast Cancer Res Treat. 2013 Aug;141(1):111-7. doi: 10.1007/s10549-013-2659-y. Epub 2013 Aug 14. — View Citation

Hocke C, Diaz M, Bernard V, Frantz S, Lambert M, Mathieu C, Grellety-Cherbero M. [Genitourinary menopause syndrome. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. Gynecol Obstet Fertil Senol. 2021 May;49(5):394-413. doi: 10.1016/j.gofs.2021.03.025. Epub 2021 Mar 20. French. — View Citation

Lanzafame RJ, de la Torre S, Leibaschoff GH. The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes. Photobiomodul Photomed Laser Surg. 2019 Jul;37(7):395-407. doi: 10.1089/photob.2019.4618. Epub 2019 Jun 17. — View Citation

Maris E, Salerno J, Hedon B, Mares P. [Management of vulvovaginal atrophy: Physical therapies. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. Gynecol Obstet Fertil Senol. 2021 May;49(5):414-419. doi: 10.1016/j.gofs.2021.03.021. Epub 2021 Mar 20. French. — View Citation

Ribi K, Luo W, Bernhard J, Francis PA, Burstein HJ, Ciruelos E, Bellet M, Pavesi L, Lluch A, Visini M, Parmar V, Tondini C, Kerbrat P, Perello A, Neven P, Torres R, Lombardi D, Puglisi F, Karlsson P, Ruhstaller T, Colleoni M, Coates AS, Goldhirsch A, Price KN, Gelber RD, Regan MM, Fleming GF. Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol. 2016 May 10;34(14):1601-10. doi: 10.1200/JCO.2015.64.8675. Epub 2016 Mar 28. — View Citation

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* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual satisfaction score on one dimension of the SHQ-22 questionnaire	Evaluation by sexual health questionnaire (SHQ-22). The SHQ-22 questionnaire is a multidimensional quality of life instrument used to measure sexual health in patients with cancer (men or women). This new tool covers both sexual functioning and psychosexual components. It includes 8 items on sexual satisfaction, 3 items on sexual pain, and 11 single items in an integrative approach, leading to 7 functional scales and 4 symptom scales. In these questionnaires, higher scores in the functioning scales indicate a better functional level, whereas higher scores in the symptom scales indicate the severity of problems.	From baseline to 1 year
Secondary	Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire	Evaluation by sexual health questionnaire (SHQ-22). The SHQ-22 questionnaire is a multidimensional quality of life instrument used to measure sexual health in patients with cancer (men or women). This new tool covers both sexual functioning and psychosexual components. It includes 8 items on sexual satisfaction, 3 items on sexual pain, and 11 single items in an integrative approach, leading to 7 functional scales and 4 symptom scales. In these questionnaires, higher scores in the functioning scales indicate a better functional level, whereas higher scores in the symptom scales indicate the severity of problems.	From baseline to 1 year
Secondary	Patient Global Impression of Improvement (PGI-I) score	Evaluation by questionnaire Patient Global Impression of Improvement (PGI-I). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 to 7. Very much better (1) to Very much worse (7).	From baseline to 1 year
Secondary	Determination of the Vaginal Health Index clinical score	The vaginal health index scores five different signs of vaginal health on a one-to-five ranking system. The lower your score, the more unhealthy your vaginal tissue is. The score ranges from 5 (the worst vaginal health) to 25 (the best vaginal health). This scoring system helps doctors to diagnose the severity of genitourinary syndrome of menopause.	From baseline to 1 year
Secondary	Determination of symptoms of vulvovaginal atrophy by a visual numerical scale	Visual numerical scale from 0 (no pain and discomfort) to 10 (the most intense pain and discomfort)	From baseline to 1 year
Secondary	Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute.		From baseline to 1 year
Secondary	Number of patients taking other treatments for treating sexual troubles		From baseline to 1 year