Gynecologic CancerPhase 4NCT03801031
Sexual Dysfunction in Gynecologic Oncology Patients
A Phase 4 study testing Lidocaine Topical in people with Gynecologic Cancer and Sexual Dysfunction, run by David Bender at 1 site in United States.
Trial summary
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic cancer. The subjects will complete a set of questionnaires about health, daily living, sexual encounters, and pain before their surgery and three times following. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Gynecologic Cancer, Sexual Dysfunction
- What is being tested?
- Lidocaine Topical
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 3 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18-99
- Planned to undergo primary surgical treatment at the University of Iowa Hospitals and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer
- Able to give informed consent and follow study procedures
- No previous reactions to lidocaine applications
- Performance Status of 0 or 1
- Reports having engaged in vaginal intercourse at least once in the last 12 months
Who cannot join
- Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery (subjects will not be eligible to continue the trial beyond the initial completion of the questionnaires)
- Diagnosis of another malignancy within the past five years, excluding basal cell carcinoma of the skin
- Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant vaginal brachytherapy)
- Previous reactions to lidocaine applications
- Previous reactions to lidocaine for the subjects' sexual partner(s)
Trial locations and contacts
1 site in 1 country.
About this study
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic cancer. The subjects will complete a set of questionnaires about health, daily living, sexual encounters, and pain before their surgery and three times following. Each subject will be randomized to receive either lidocaine or a placebo that is applied vaginally immediately prior to any sexual encounters for approximately 6 months while maintaining a journal of sexual encounters and pain. The subjects and healthcare providers will be blinded to the treatment randomization until intervention and data collection is complete. Total participation will last up to one year from the date of enrollment. Subjects will visit the clinic at the same time as regular cancer care visits, receive the blinded intervention and complete the surveys.
Read the detailed description
Once consented, subjects will complete nine short surveys (The Female Sexual Function Index, The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index, the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit, assessing physical, psychological, and social elements related to sexuality.
Subjects will then have the tumor reduction surgery.
Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey packet.
Once the second packet is completed, subjects will be randomized to receive either aqueous lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and place them on the perineum/vaginal introitus for one minute prior to sexual intercourse. Subjects will be educated on the use of this blinded intervention and be asked to keep a diary of sexual encounters, including a simple pictorial pain scale for each encounter. Subjects and providers are blinded to the assigned intervention.
Once subjects complete three months of perineal intervention, they will be asked at a follow-up visit (12 weeks following randomization) to complete the survey packet for a third time.
Subjects will then continue their perineal intervention, keep a diary of sexual encounters with the pain scale and return after another three-month interval for a fourth completion of the survey packet. Sexual encounter diaries and pain scale assessments will be collected and their participation in the trial will conclude. Also at the time of this concluding follow-up visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic oncologist regarding education about sexual dysfunction, the possibility of experiencing sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The subject will remain blinded to the randomized intervention until the conclusion of the study.
Subjects will be unblinded and informed of assigned intervention at the conclusion of the study via a letter sent to their home address from the researchers.
- Conditions
- Gynecologic Cancer, Sexual Dysfunction
- Being tested
- Lidocaine Topical, Placebo
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine TopicalDrug
Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.
PlaceboDrug
Placebo solution intervention used to validate the effects of the lidocaine solution usage.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters. Receives: Drug: Lidocaine Topical |
| Placebo | Placebo comparator | Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Sexual Function
Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.
Measured: 9 months
Changes in Pain
Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.
Measured: 9 months
Secondary outcomes (8)
Depressive Symptoms
Mean Change in Patient Health Questionnaire 9 (PHQ-9), a 9-item self-report instrument to screen for depression. Responses range from 0-3 and the scores range from 0-27, the higher total score indicates more depression.
Measured: 9 months
Anxiety
Mean change in Generalized Anxiety Disorder 7-item scale (GAD-7), a brief self-report instrument of 7 items to assess generalized anxiety disorder. Responses range from 0-3 and the scores range from 0-21, the higher total score indicates more anxiety.
Measured: 9 months
Relationships and Social Support
Mean change in Social Provisions Scale, a 24-item self-reported survey measuring perceived social support to assess confounders on sexual function. Responses range from 1-4 and higher total scores indicate greater social connection.
Measured: 9 months
Self-Esteem
Mean change of Rosenberg's Body Self-Esteem Index, a 10-item self-report survey assessing global self-worth by measuring both positive and negative feelings about the self. Total scores range between 0 and 40; higher scores indicate better self-esteem.
Measured: 9 months
Posttraumatic Stress Symptoms
Scores of Severity of Posttraumatic Stress Symptoms-Adult survey, a 9-item self-report instrument that assesses severity of posttraumatic stress disorder following a particular event or experience. Responses range from 0-4, 0 indicating no distress and 4 indicating extreme distress. Each item is measured on a 5-point scale (0=not at all; 4=extremely). Total score can range from 0-36 or averaged for 0-5. The higher scores indicate more severe PTS distress.
Measured: 9 months
Adverse Childhood Events
Presence, Severity, or Mean Change in Adverse Childhood Events Index, a 10-item self-report scale measuring types of physical, verbal, and emotional childhood trauma. Items are responded with yes or no. The total score is the sum of yes responses and range from 0-10. Higher total scores indicate more adverse childhood experiences.
Measured: 9 months
Health Status
Mean Change in SF-12, a 12-item self-report measure of perceived general health status and disability. Responses include yes or no or ranges on 5- or 6-point scales. Higher total scores indicate more disability.
Measured: 9 months
Romantic Relationships
Mean Change in Dyadic Adjustment Scale (DAS), a 32-item self-report measure of couple satisfaction. Responses are 5- or 6-point scales or yes or no. Total scores range from 0 to 151. Higher total scores indicate higher adjustment and satisfaction in intimate relationships.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start6 Jun 2019
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Bender
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Bender, University of Iowa
- Investigators
- David Bender, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801031
- Sponsor's protocol ID
- 201609770
- Status last verified
- Nov 2022
- First submitted
- 9 Jan 2019
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbott-Anderson K, Kwekkeboom KL. A systematic review of sexual concerns reported by gynecological cancer survivors. Gynecol Oncol. 2012 Mar;124(3):477-89. doi: 10.1016/j.ygyno.2011.11.030. Epub 2011 Nov 28.
PubMed 22134375
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Gynecologic Oncology Patients
- ClinicalTrials.gov ID
- NCT03801031
- Acronym / sponsor ID
- 201609770
- Conditions
- Gynecologic Cancer, Sexual Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- David BenderUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 6 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic cancer. The subjects will complete a set of questionnaires about health, daily living, sexual encounters, and pain before their surgery and three times following. Each subject will be randomized to receive either lidocaine or a placebo that is applied vaginally immediately prior to any sexual encounters for approximately 6 months while maintaining a journal of sexual encounters and pain. The subjects and healthcare providers will be blinded to the treatment randomization until intervention and data collection is complete. Total participation will last up to one year from the date of enrollment. Subjects will visit the clinic at the same time as regular cancer care visits, receive the blinded intervention and complete the surveys.
Detailed description
Once consented, subjects will complete nine short surveys (The Female Sexual Function Index, The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index, the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit, assessing physical, psychological, and social elements related to sexuality.
Subjects will then have the tumor reduction surgery.
Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey packet.
Once the second packet is completed, subjects will be randomized to receive either aqueous lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and place them on the perineum/vaginal introitus for one minute prior to sexual intercourse. Subjects will be educated on the use of this blinded intervention and be asked to keep a diary of sexual encounters, including a simple pictorial pain scale for each encounter. Subjects and providers are blinded to the assigned intervention.
Once subjects complete three months of perineal intervention, they will be asked at a follow-up visit (12 weeks following randomization) to complete the survey packet for a third time.
Subjects will then continue their perineal intervention, keep a diary of sexual encounters with the pain scale and return after another three-month interval for a fourth completion of the survey packet. Sexual encounter diaries and pain scale assessments will be collected and their participation in the trial will conclude. Also at the time of this concluding follow-up visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic oncologist regarding education about sexual dysfunction, the possibility of experiencing sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The subject will remain blinded to the randomized intervention until the conclusion of the study.
Subjects will be unblinded and informed of assigned intervention at the conclusion of the study via a letter sent to their home address from the researchers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine TopicalPatients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters. |
| Placebo | Placebo comparator | Drug: PlaceboPatients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Age 18-99
- Planned to undergo primary surgical treatment at the University of Iowa Hospitals and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer
- Able to give informed consent and follow study procedures
- No previous reactions to lidocaine applications
Key exclusion criteria (5 listed)
- Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery (subjects will not be eligible to continue the trial beyond the initial completion of the questionnaires)
- Diagnosis of another malignancy within the past five years, excluding basal cell carcinoma of the skin
- Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant vaginal brachytherapy)
- Previous reactions to lidocaine applications
- Previous reactions to lidocaine for the subjects' sexual partner(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine TopicalMany women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention. | Drug | Lidocaine |
| PlaceboPlacebo solution intervention used to validate the effects of the lidocaine solution usage. | Drug | Placebo |
Primary outcome
Changes in Sexual Function
Time frame: 9 months
Sexual function measured by the Female Sexual Function Index (FSFI) survey, a 19-item self-report survey measuring sexual function. Item responses are on a 5-point scale and the total scores range 2 to 36 points, considering that the higher the score obtained, the better the sexual function of the woman.
Changes in Pain
Time frame: 9 months
Pain is measured by using the visual analog scale for pain, which is a scale of 0-10, utilizing numbers and face illustrations to describe pain level. Pain level is measured on a 0-10 point scale, 0 indicating no pain and 10 indicating the worst pain possible.
8 secondary outcomes
Depressive Symptoms
Time frame: 9 months
Anxiety
Time frame: 9 months
Relationships and Social Support
Time frame: 9 months
Self-Esteem
Time frame: 9 months
Posttraumatic Stress Symptoms
Time frame: 9 months
Adverse Childhood Events
Time frame: 9 months
Health Status
Time frame: 9 months
Romantic Relationships
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22134375Abbott-Anderson K, Kwekkeboom KL. A systematic review of sexual concerns reported by gynecological cancer survivors. Gynecol Oncol. 2012 Mar;124(3):477-89. doi: 10.1016/j.ygyno.2011.11.030. Epub 2011 Nov 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bender, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Topical in people with Gynecologic Cancer and Sexual Dysfunction, run by David Bender at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Sexual Function (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.