Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study (SAPPHIRE)

April 4, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SINGLE-ARM INTERVENTIONAL STUDY
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)
Other: Assessment of sexual quality of life
The following questionnaires will be completed : EORTC QLQ-SH22 questionnaire, Questionnaire on the impact of HPV infection, HADS questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the quality of sexual life among patients treated (radiotherapy, with or without chemotherapy, and/or surgery) as part of the management of HPV-positive pelvic cancer.
Time Frame: at baseline, 3 months and 6 months after the end of all cancer treatment
Sexual quality of life scores obtained from the European EORTC QLQ-SH22 questionnaire
at baseline, 3 months and 6 months after the end of all cancer treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess perceptions of, and the impact on sexuality of, the sexually transmitted nature (STI) of these cancers
Time Frame: at baseline, 3 months and 6 months after the end of all cancer treatment
Questionnaire on the impact of HPV infection
at baseline, 3 months and 6 months after the end of all cancer treatment
Describe the progression of psychological distress
Time Frame: at inclusion, at 3 months, at 6 months
Psychological distress scores obtained using the HADS scale, including scores for depression and anxiety.
at inclusion, at 3 months, at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Director: MOUSSION AURORE, DRCI ICM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2025-06 OSA
  • IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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