Sexual Dysfunction in Gynecologic Oncology Patients
Condition: Gynecologic Cancer; Sexual Dysfunction
Intervention: Lidocaine Topical; Placebo
Intervention description: 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.; Placebo solution intervention used to validate the effects of the lidocaine solution usage.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

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.
    

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)