Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Topical saline
- Conditions
- Vulvodynia
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Location of Pain in Postmenopausal Dyspareunia
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.
The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.
Detailed Description
For this study there will be three visits over a 3 month period. Subjects will undergo a gynecological exam at the screening visit to determine the severity of pain associated with uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so subjects can report pain during application of both study drug and placebo. Subjects will also report pain during tampon test. A sample of vaginal cells and liquid will be obtained at screening visit so that PI can rule out possible infection, disease, or disorders. PI will also show subject the area of the vestibule in a mirror so that subject can apply study drug at home properly. Subjects will fill out 4 questionnaires about medical and health history, cancer history, pain, and distress and sexual activity. Subject will be given a supply of either study drug or placebo to take home. The first visit will last approximately 2 hours. Subjects will return for a second visit after 4 weeks and a third visit after 8 weeks for diary review, questionnaires, and examination. The second and third visit examinations will be repeats of the examination done at the first visit, but there will be no comparison with placebo, the PI will use only study drug during the touch test. The second and third visits will last approximately 1 hour. Subjects will fill out questionnaires throughout study participation. Topics include; medical and health history, cancer history, pain, distress and sexual activity. Subjects will also fill out a diary that charts tampon test completed from home, sexual activity performed, pain levels and study drug application days.
Investigators
Martha Goetsch
Assistant Professor
OHSU Knight Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Topical liquid lidocaine
Intervention: Topical saline
Topical liquid lidocaine
Intervention: Topical liquid lidocaine
Topical Saline
Intervention: Topical liquid lidocaine
Topical Saline
Intervention: Topical saline
Outcomes
Primary Outcomes
Location of Pain in Postmenopausal Dyspareunia
Time Frame: Enrollment visit
To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".
Prevention of Entry Dyspareunia With Non-hormonal Therapy
Time Frame: During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being "no pain" and 10 being "worst possible pain"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.
Secondary Outcomes
- Improvement of Quality of Sexual Life - Visit 1(Visit 1 (Enrollment))
- Improvement of Quality of Sexual Life - Visit 2(Visit 2 (Week 4))
- Improvement of Quality of Sexual Life - Visit 3(Visit 3 (End of Study))