Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer (GRASS)

October 4, 2023 updated by: Royal Marsden NHS Foundation Trust

Using Fat Tissue GRafting to Treat Symptoms of VAginal Stenosis in Women With Gynaecological Cancer - IDEAL Stage 2a Surgical Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

8

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 Locations

  • United Kingdom
      • London, United Kingdom, SW36JJ
        • The Royal Marsden NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Marielle Ms Nobbenhuis

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fat Grafting
The fat grafting procedure will be conducted as per local standard RM protocol. All procedures will be conducted by the study Principal Investigator (PI) who is well practiced in performing this procedure in Head & Neck and breast cancer patients and also in scar revision patients.
Procedure: Fat Graft
Fat grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients able to have vaginal penetration without pain (yes / no)
Time Frame: 11 months
Ability to have vaginal penetration , this is descriptive and will be provided as a yes / no answer by the patient at their follow up visit
11 months
Number of patients with an increase in the volume of the rectovaginal septum on pelvic MRI imaging
Time Frame: 10 months
Increase in the volume of the rectovaginal septum on pelvic MRI imaging
10 months
Number of patients with reduced scarring on vaginal biopsies
Time Frame: 10 months
Fat:Fibrosis ratio and total far and fibrosis percentage (as a percentage of the total stroma)
10 months
Improvement in sexual wellbeing
Time Frame: 11 months
Measured using the Sexual Well-Being After Cervical or Endometrial Cancer (SWELL-CE) questionnaire (11) - a score drop below 9 (a score of 9 or above represents significant sexual difficulties)
11 months
Improvement in cervical cancer specific quality of life
Time Frame: 11 months
Cervical cancer specific quality of life measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-CX24 - 10% improvement of the scale range for MCID (minimally clinically important differences)
11 months
Improvement in overall quality of life
Time Frame: 11 months
Overall quality of life measured using the EORTC QLQ-C30. Any improvement in overall score will be deemed as an improvement
11 months
Improvement in overall quality of life
Time Frame: 11 months
Overall quality of life measured using the EUROQOL EQ-5D-5L. Any improvement in overall score will be deemed as an improvement
11 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Calvien Dindo complications
Time Frame: 11 months
Occurrence of Calvien Dindo complications (≥grade 3 ) post treatment
11 months
Determination of patient acceptability of the research procedure and of the trial
Time Frame: 11 months
Determination of patient acceptability of the research procedure and of the trial will be explored in a focus group
11 months
Recruitment
Time Frame: 6 months
Number of patients screened eligible, number approached and number of patients who consent to take part
6 months
Retention
Time Frame: 12 months
Assess the proportion of patients who complete each planned fat graft treatment
12 months

Collaborators and Investigators

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

Sponsor

Royal Marsden NHS Foundation Trust

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)

October 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5742

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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