NCT06015360

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

June 8, 2023

Last Update Submit

October 4, 2023

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (7)

  • Number of patients able to have vaginal penetration without pain (yes / no)

    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

    Increase in the volume of the rectovaginal septum on pelvic MRI imaging

    10 months

  • Number of patients with reduced scarring on vaginal biopsies

    Fat:Fibrosis ratio and total far and fibrosis percentage (as a percentage of the total stroma)

    10 months

  • Improvement in sexual wellbeing

    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

    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

    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

    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 Outcomes (4)

  • Occurrence of Calvien Dindo complications

    11 months

  • Determination of patient acceptability of the research procedure and of the trial

    11 months

  • Recruitment

    6 months

  • Retention

    12 months

Study Arms (1)

Fat Grafting

EXPERIMENTAL

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

Interventions

Fat GraftPROCEDURE

Fat grafting

Fat Grafting

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW36JJ, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2023

First Posted

August 29, 2023

Study Start

October 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)