Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer

Trial Title: Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer

NCT ID: NCT06015360

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Fat Graft
Description: Fat grafting
Arm group label: Fat Grafting

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.

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Female patients

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Royal Marsden NHS Foundation Trust

Address:
City: London
Zip: SW36JJ
Country: United Kingdom

Contact:
Last name: Mark Brandon-Grove

Phone: 02031865416
Email: Mark.Brandon-Grove@rmh.nhs.uk

Investigator:
Last name: Marielle Ms Nobbenhuis
Email: Principal Investigator

Start date: October 2023

Completion date: September 2025

Lead sponsor:
Agency: Royal Marsden NHS Foundation Trust
Agency class: Other

Source: Royal Marsden NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06015360