Clinical trial NCT03801031: Sexual Dysfunction in Gynecologic Oncology Patients
Official title: Sexual Dysfunction in Gynecologic Oncology Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gynecologic Cancer
Sexual Dysfunction
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion criteria

* 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

Exclusion criteria:

* 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)

Primary outcomes:
measure: Changes in Sexual Function
timeFrame: 9 months
measure: Changes in Pain
timeFrame: 9 months
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: 9 months
measure: Anxiety
timeFrame: 9 months
measure: Relationships and Social Support
timeFrame: 9 months
measure: Self-Esteem
timeFrame: 9 months
measure: Posttraumatic Stress Symptoms
timeFrame: 9 months
measure: Adverse Childhood Events
timeFrame: 9 months
measure: Health Status
timeFrame: 9 months
measure: Romantic Relationships
timeFrame: 9 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: David Bender, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.