Sexual Dysfunction in Gynecologic Oncology Patients

NCT03801031 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 201609770
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Sexual Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  9 months

Secondary Outcomes (8)

• Depressive Symptoms

  9 months

• Anxiety

  9 months

• Relationships and Social Support

  9 months

• Self-Esteem

  9 months

• Posttraumatic Stress Symptoms

  9 months

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters.

Drug: Lidocaine Topical

Placebo

PLACEBO COMPARATOR

Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.

Drug: Placebo

Interventions

Lidocaine Topical DRUG

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.

Lidocaine

Placebo DRUG

Placebo solution intervention used to validate the effects of the lidocaine solution usage.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• David Bender: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 22134375 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

This study stopped accrual early due to unmet targeted accrual goals with 4 subjects accrued out of 120 planned.

Results Point of Contact

• Title: David Bender, MD
• Organization: University of Iowa

david-bender@uiowa.edu

319-356-2015

Study Officials

• David Bender, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: June 6, 2019
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: December 6, 2022
• Results First Posted: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)