Therapy to Prevent Sexual Pain in Breast Cancer Survivors

Phase 3

Completed

Conditions: Menopause
Dyspareunia
Vulvodynia
Breast Cancer

Interventions: Drug: Topical liquid lidocaine
Drug: Topical saline

Registration Number: NCT01539317

Lead Sponsor: OHSU Knight Cancer Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Topical Saline	Topical liquid lidocaine	-
Topical liquid lidocaine	Topical saline	-
Topical liquid lidocaine	Topical liquid lidocaine	-
Topical Saline	Topical saline	-

Primary Outcome Measures

Name	Time	Method
Location of Pain in Postmenopausal Dyspareunia	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	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 Outcome Measures

Name	Time	Method
Improvement of Quality of Sexual Life - Visit 1	Visit 1 (Enrollment)	To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).
Improvement of Quality of Sexual Life - Visit 2	Visit 2 (Week 4)	To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).
Improvement of Quality of Sexual Life - Visit 3	Visit 3 (End of Study)	To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).