Therapy to Prevent Sexual Pain in Breast Cancer Survivors
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2015
CompletedApril 14, 2017
April 1, 2017
1.9 years
December 21, 2011
June 5, 2015
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevention of Entry Dyspareunia With Non-hormonal Therapy
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.
During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
Location of Pain in Postmenopausal Dyspareunia
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".
Enrollment visit
Secondary Outcomes (3)
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)
Study Arms (2)
Topical liquid lidocaine
ACTIVE COMPARATORTopical Saline
PLACEBO COMPARATORInterventions
active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule
saline applied to the vestibule mucosa will not reverse the local tenderness
Eligibility Criteria
You may not qualify if:
- Diagnosis of benign or malignant phyllodes tumor of the breast.
- Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
- Has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam).
- Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
- The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
- Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
- Potential subject has used topical or systemic estrogen within the last 4 months.
- Has continued tenderness of vestibule mucosa immediately after application of both test liquids.
- Allergy to lidocaine or other numbing agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (2)
Goetsch MF, Lim JY, Caughey AB. A Practical Solution for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 20;33(30):3394-400. doi: 10.1200/JCO.2014.60.7366. Epub 2015 Jul 27.
PMID: 26215946DERIVEDGoetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283.
PMID: 24807329DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Martha Goetsch
- Organization
- Oregon Health and Science University
Study Officials
- PRINCIPAL INVESTIGATOR
Martha Goetsch, MD
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 21, 2011
First Posted
February 27, 2012
Study Start
December 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
April 14, 2017
Results First Posted
August 4, 2015
Record last verified: 2017-04