xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015360</url>
    </required_header>
    <id_info>
      <org_study_id>CCR5742</org_study_id>
      <nct_id>NCT06015360</nct_id>
    </id_info>
    <brief_title>Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer</brief_title>
    <acronym>GRASS</acronym>
    <official_title>Using Fat Tissue GRafting to Treat Symptoms of VAginal Stenosis in Women With Gynaecological Cancer - IDEAL Stage 2a Surgical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal Marsden NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Royal Marsden NHS Foundation Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The GRASS study looks at performing a technique called &quot;Fat Tissue Grafting&quot; to assess&#xD;
        whether it can reduce the side effects of vaginal stenosis effects and improve the sexual&#xD;
        function of participants who wish to preserve penetrative sexual function&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Vaginal stenosis is a common sequelae of radiotherapy treatment for cervical cancer. This can&#xD;
        cause significant sexual problems resulting in sexual avoidance, relationship problems,&#xD;
        feelings of low self-esteem, isolation, and difficulties initiating new relationships.&#xD;
        Vaginal changes resulting in narrowing (stenosis) and adhesions can also lead to painful&#xD;
        vaginal examinations which are routinely performed during follow-up consultations.&#xD;
  &#xD;
        The available treatments for vaginal problems include regular use of vaginal dilators,&#xD;
        lubricants, and moisturisers, all of which have shown poor results despite requiring an&#xD;
        incessant effort by women.&#xD;
  &#xD;
        A technique called 'fat grafting' has been successfully and safely used for many years to&#xD;
        rectify the cosmetic and functional consequences of Breast and Head and Neck Cancers&#xD;
        treatments. This technique is performed under general anaesthesia and uses fat tissue that is&#xD;
        removed from other parts of the body; usually thighs, abdomen, and buttocks, by liposuction.&#xD;
        The fat tissue is then processed into liquid and injected into the required area to generate&#xD;
        more elasticity and improve tissue quality. To our knowledge this technique has never been&#xD;
        applied to the field of Gynaecology-oncology.&#xD;
  &#xD;
        In 2021 this technique was used in one patient with severe vaginal stenosis after&#xD;
        radiotherapy treatment for advanced cervical cancer, by the Gynaecological and Plastic&#xD;
        surgical teams at the Royal Marsden Hospital (RM). The fat tissue was harvested and processed&#xD;
        using the method as described and injected into the vagina area (rectovaginal wall) with the&#xD;
        aim being to generate more elasticity and improve the quality of the vaginal tissue. As a&#xD;
        result of the procedure, the patient now reports reduction in vaginal bleeding and pain&#xD;
        experienced, and a noticeable improvement in the size of the vagina allowing for penetrative&#xD;
        sex.&#xD;
  &#xD;
        This innovative technique addresses a neglected and unmet need of women to manage a&#xD;
        consequence of curative treatment that is underreported and often unrecognised. It also&#xD;
        serves as an example of how cross-discipline work focused on real patients' needs can produce&#xD;
        ground-breaking solutions to complex clinical conundrums, by mobilising highly specialist&#xD;
        clinical experts.&#xD;
  &#xD;
        If this programme is successful, it can be expanded to women with vaginal stenosis due to&#xD;
        radiotherapy for other cancers e.g., colorectal, or urological cancer. In addition, the&#xD;
        investigators the investigators will work in partnership with the patient(s) who successfully&#xD;
        benefit from fat grafting treatment to guide the development of a larger study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients able to have vaginal penetration without pain (yes / no)</measure>
      <time_frame>11 months</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with an increase in the volume of the rectovaginal septum on pelvic MRI imaging</measure>
      <time_frame>10 months</time_frame>
      <description>Increase in the volume of the rectovaginal septum on pelvic MRI imaging</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with reduced scarring on vaginal biopsies</measure>
      <time_frame>10 months</time_frame>
      <description>Fat:Fibrosis ratio and total far and fibrosis percentage (as a percentage of the total stroma)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement in sexual wellbeing</measure>
      <time_frame>11 months</time_frame>
      <description>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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement in cervical cancer specific quality of life</measure>
      <time_frame>11 months</time_frame>
      <description>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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement in overall quality of life</measure>
      <time_frame>11 months</time_frame>
      <description>Overall quality of life measured using the EORTC QLQ-C30. Any improvement in overall score will be deemed as an improvement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement in overall quality of life</measure>
      <time_frame>11 months</time_frame>
      <description>Overall quality of life measured using the EUROQOL EQ-5D-5L. Any improvement in overall score will be deemed as an improvement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occurrence of Calvien Dindo complications</measure>
      <time_frame>11 months</time_frame>
      <description>Occurrence of Calvien Dindo complications (≥grade 3 ) post treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of patient acceptability of the research procedure and of the trial</measure>
      <time_frame>11 months</time_frame>
      <description>Determination of patient acceptability of the research procedure and of the trial will be explored in a focus group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recruitment</measure>
      <time_frame>6 months</time_frame>
      <description>Number of patients screened eligible, number approached and number of patients who consent to take part</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retention</measure>
      <time_frame>12 months</time_frame>
      <description>Assess the proportion of patients who complete each planned fat graft treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Cervical Cancer</condition>
    <arm_group>
      <arm_group_label>Fat Grafting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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 &amp; Neck and breast cancer patients and also in scar revision patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fat Graft</intervention_name>
      <description>Fat grafting</description>
      <arm_group_label>Fat Grafting</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with cervical cancer&#xD;
  &#xD;
            -  At least 2 years since finishing pelvic radiotherapy for gynaecological cancer&#xD;
  &#xD;
            -  Treated at RM&#xD;
  &#xD;
            -  Persistent symptoms of vaginal stenosis despite prior use of vaginal dilators/&#xD;
               oestrogen replacement / lubricants/moisturisers&#xD;
  &#xD;
            -  Desiring vaginal intercourse&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Evidence of recurrent disease documented on Magnetic Resonance Imaging (MRI)&#xD;
  &#xD;
            -  Patients unwilling / unable to provide written informed consent for the study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female patients</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Royal Marsden NHS Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>SW36JJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Mark Brandon-Grove</last_name>
        <phone>02031865416</phone>
        <email>Mark.Brandon-Grove@rmh.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Marielle Ms Nobbenhuis</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015360
  org study id: CCR5742
  nct id: NCT06015360
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of patients able to have vaginal penetration without pain (yes / no)
  time frame: 11 months
  description: 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
  measure: Number of patients with an increase in the volume of the rectovaginal septum on pelvic MRI imaging
  time frame: 10 months
  description: Increase in the volume of the rectovaginal septum on pelvic MRI imaging
  measure: Number of patients with reduced scarring on vaginal biopsies
  time frame: 10 months
  description: Fat:Fibrosis ratio and total far and fibrosis percentage (as a percentage of the total stroma)
  measure: Improvement in sexual wellbeing
  time frame: 11 months
  description: 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)
  measure: Improvement in cervical cancer specific quality of life
  time frame: 11 months
  description: 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)
  measure: Improvement in overall quality of life
  time frame: 11 months
  description: Overall quality of life measured using the EORTC QLQ-C30. Any improvement in overall score will be deemed as an improvement
  measure: Improvement in overall quality of life
  time frame: 11 months
  description: Overall quality of life measured using the EUROQOL EQ-5D-5L. Any improvement in overall score will be deemed as an improvement
  measure: Occurrence of Calvien Dindo complications
  time frame: 11 months
  description: Occurrence of Calvien Dindo complications (≥grade 3 ) post treatment
  measure: Determination of patient acceptability of the research procedure and of the trial
  time frame: 11 months
  description: Determination of patient acceptability of the research procedure and of the trial will be explored in a focus group
  measure: Recruitment
  time frame: 6 months
  description: Number of patients screened eligible, number approached and number of patients who consent to take part
  measure: Retention
  time frame: 12 months
  description: Assess the proportion of patients who complete each planned fat graft treatment
  arm group label: Fat Grafting
  arm group type: Experimental
  description: 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.
  intervention type: Procedure
  intervention name: Fat Graft
  description: Fat grafting
  arm group label: Fat Grafting
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female patients
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: No