Clinical trial NCT06015360: Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer
Official title: Using Fat Tissue GRafting to Treat Symptoms of VAginal Stenosis in Women With Gynaecological Cancer - IDEAL Stage 2a Surgical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 8
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The GRASS study looks at performing a technique called "Fat Tissue Grafting" to assess whether it can reduce the side effects of vaginal stenosis effects and improve the sexual function of participants who wish to preserve penetrative sexual function

Detailed description: Vaginal stenosis is a common sequelae of radiotherapy treatment for cervical cancer. This can cause significant sexual problems resulting in sexual avoidance, relationship problems, feelings of low self-esteem, isolation, and difficulties initiating new relationships. Vaginal changes resulting in narrowing (stenosis) and adhesions can also lead to painful vaginal examinations which are routinely performed during follow-up consultations.

The available treatments for vaginal problems include regular use of vaginal dilators, lubricants, and moisturisers, all of which have shown poor results despite requiring an incessant effort by women.

A technique called 'fat grafting' has been successfully and safely used for many years to rectify the cosmetic and functional consequences of Breast and Head and Neck Cancers treatments. This technique is performed under general anaesthesia and uses fat tissue that is removed from other parts of the body; usually thighs, abdomen, and buttocks, by liposuction. The fat tissue is then processed into liquid and injected into the required area to generate more elasticity and improve tissue quality. To our knowledge this technique has never been applied to the field of Gynaecology-oncology.

In 2021 this technique was used in one patient with severe vaginal stenosis after radiotherapy treatment for advanced cervical cancer, by the Gynaecological and Plastic surgical teams at the Royal Marsden Hospital (RM). The fat tissue was harvested and processed using the method as described and injected into the vagina area (rectovaginal wall) with the aim being to generate more elasticity and improve the quality of the vaginal tissue. As a result of the procedure, the patient now reports reduction in vaginal bleeding and pain experienced, and a noticeable improvement in the size of the vagina allowing for penetrative sex.

This innovative technique addresses a neglected and unmet need of women to manage a consequence of curative treatment that is underreported and often unrecognised. It also serves as an example of how cross-discipline work focused on real patients' needs can produce ground-breaking solutions to complex clinical conundrums, by mobilising highly specialist clinical experts.

If this programme is successful, it can be expanded to women with vaginal stenosis due to radiotherapy for other cancers e.g., colorectal, or urological cancer. In addition, the investigators the investigators will work in partnership with the patient(s) who successfully benefit from fat grafting treatment to guide the development of a larger study.

Eligibility criteria: Inclusion Criteria:

* Patients with cervical cancer
* At least 2 years since finishing pelvic radiotherapy for gynaecological cancer
* Treated at RM
* Persistent symptoms of vaginal stenosis despite prior use of vaginal dilators/ oestrogen replacement / lubricants/moisturisers
* Desiring vaginal intercourse

Exclusion Criteria:

* Evidence of recurrent disease documented on Magnetic Resonance Imaging (MRI)
* Patients unwilling / unable to provide written informed consent for the study

Primary outcomes:
measure: Number of patients able to have vaginal penetration without pain (yes / no)
timeFrame: 11 months
measure: Number of patients with an increase in the volume of the rectovaginal septum on pelvic MRI imaging
timeFrame: 10 months
measure: Number of patients with reduced scarring on vaginal biopsies
timeFrame: 10 months
measure: Improvement in sexual wellbeing
timeFrame: 11 months
measure: Improvement in cervical cancer specific quality of life
timeFrame: 11 months
measure: Improvement in overall quality of life
timeFrame: 11 months
measure: Improvement in overall quality of life
timeFrame: 11 months
Secondary outcomes:
measure: Occurrence of Calvien Dindo complications
timeFrame: 11 months
measure: Determination of patient acceptability of the research procedure and of the trial
timeFrame: 11 months
measure: Recruitment
timeFrame: 6 months
measure: Retention
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
References: