| Registry | NCT07523152, acronym SAPPHIRE |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 42 (Estimated) |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle (Other) |
| Conditions | Pelvic Cancer, Anal Cancer, Vaginal Cancer |
| Interventions | Assessment of sexual quality of life (Other) |
| Dates | start 2026-04-02 (estimated), primary completion 2027-10-31 (estimated), completion 2027-10-31 (estimated), first posted 2026-04-13, last updated 2026-04-13 |
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All trials for Pelvic Cancer All trials for Anal Cancer All trials of Assessment of sexual quality of life
In patients with cancer associated with human papillomavirus (HPV), the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can further impair the quality of sexual life.
However, few studies have examined the specific effect of HPV status (or knowledge of status) on the recovery/quality of sexuality following radiotherapy.
It is against this backdrop that we propose a prospective longitudinal study specifically dedicated to investigating the sexual quality of life of women with HPV-positive pelvic cancer.
This type of study will enable better quantification and description of sexual dysfunction occurring after treatment, and assessment of the impact of HPV carriage, with the future aim of guiding new prevention and management strategies.
Surgery for HPV-related pelvic cancers has a significant impact on patients' sexual quality of life.
In cervical cancer, several studies show a lasting impairment of sexual function following hysterectomy, particularly when it is radical. Long-term follow-up of patients confirms that these difficulties persist for several years after treatment and are influenced by factors such as age, hormonal status or the combination with other treatment modalities.
For vulvar and vaginal cancers, surgery frequently leads to disruptions in sexual life linked to anatomical changes and body image. A review of the literature highlights a high prevalence of dyspareunia, orgasmic disorders and reduced desire following vulvectomy, with significant psychosocial repercussions.
Finally, in anal canal cancer, abdominoperineal resection is particularly detrimental due to the anatomical and neurological sequelae it causes. Sexual quality of life is further impaired when a stoma is created, further impacting body image and self-esteem.
Reviews and studies focusing on women following cervical and other pelvic cancers show a high prevalence of sexual dysfunction (problems with desire, arousal, lubrication, pain, and reduced satisfaction).
Knowing that the cancer being treated is linked to a sexually transmitted HPV infection can lead to anxiety, guilt, relationship difficulties and a negative perception of sexuality, as highlighted in several recent studies. This immediate anxiety following the diagnosis is accompanied by impaired sexual function, particularly in cases involving genotypes 16 and 18, which carry the highest risk of cancer.
However, in the long term, cross-sectional studies report more nuanced findings.
In qualitative terms, the experience often revolves around the fear of transmitting the infection, the stigma associated with STIs and difficulties in communication within the couple, but may also foster greater openness in the relationship.
In patients with HPV-associated cancer, the physical effects of treatment, combined with the psychosexual impact linked to HPV status, can exacerbate the deterioration in sexual quality of life.
Several validated tools exist for assessing sexual quality of life following radiotherapy:
* FSFI (Female Sexual Function Index) - a multidimensional measure (desire, arousal, lubrication, orgasm, satisfaction, pain), widely used among cancer survivors.
* EORTC QLQ-SH22 (SHQ-C22) questionnaire - assesses the physical, psychological and social aspects of sexual life, also validated in oncology.
* Many studies describe changes in sexual function following radiotherapy, but few isolate the impact of HPV status or specifically assess HPV-positive patients.
* Methodological variability limits generalisability and prevents an accurate estimation of the incidence and progression of sexual dysfunction following treatment in the HPV-positive subpopulation.
* Although the consequences of radiotherapy with or without pelvic surgery on patients' sexual quality of life are better understood in clinical practice, the exact prevalence and temporal progression, as well as the specific impact of HPV status, remain insufficiently described.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SINGLE-ARM INTERVENTIONAL STUDY | Experimental | Other: Assessment of sexual quality of life | Patients will be seen by the investigator at the radiotherapy clinic on enrolment, at 3 months and at 6 months (the 6-month visit will mark the end of the study) |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: 1. Women aged 18 or over. 2. Sexually active patients, i.e. those who have been sexually active in the year prior to their cancer diagnosis. 3. Patients being treated at the Montpellier Cancer Institute (ICM). 4. Patient with pelvic squamous cell carcinoma (cervix, vagina, vulva or anus) and human papillomavirus (HPV+) infection 5. Patient aware of her HPV status and how it is transmitted. 6. Indicated for external radiotherapy 7. Patient who has not received any oncological treatment prior to inclusion. 8. Patient who has given verbal consent. Exclusion Criteria: 1. Patients receiving radiotherapy treatment outside the Montpellier Cancer Institute (ICM). 2. Patients who are unwilling or unable to complete the study questionnaires. 3. Patients under guardianship, curatorship or court protection, 4. Patients for whom regular follow-up is impossible for psychological reasons, 5. Patients who do not speak French.