Therapy to Prevent Sexual Pain in Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martha Goetsch, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01539317
First received: December 21, 2011
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Vulvodynia
Dyspareunia
Breast Cancer
Menopause
Drug: Topical liquid lidocaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Entry dyspareunia relief [ Time Frame: From the date of enrollment to 6 months ] [ Designated as safety issue: No ]
    Decrease in reported pain by subjects on McGill Pain Questionnaire.


Secondary Outcome Measures:
  • Improvement of quality of sexual life. [ Time Frame: From time of enrollment until 6 months later ] [ Designated as safety issue: No ]
    To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by improved scores on the Female Sexual Distress Scale and the Sexual Function Questionnaire.


Enrollment: 50
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Topical liquid lidocaine Drug: Topical liquid lidocaine
Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
Placebo Comparator: Topical Saline Drug: Topical liquid lidocaine
Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria

  1. Women aged 18 to 70 years old.
  2. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
  3. 1 year from diagnosis of breast cancer.
  4. Stable heterosexual partnership =/>5 years or by investigator discretion.
  5. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).
  6. Menopausal, demonstrated by at least one of the following:

    i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. FSH level >25 in women below age 50 with an ovary and scarred or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist monitors FSH during aromatase inhibitor therapy).

  7. Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
  8. Willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain.

3.2 Exclusion Criteria

  1. Diagnosis of benign or malignant phyllodes tumor of the breast.
  2. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
  3. 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).
  4. Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
  5. The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
  6. Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
  7. Potential subject has used topical or systemic estrogen within the last 4 months.
  8. Has continued tenderness of vestibule mucosa immediately after application of both test liquids.
  9. Allergy to lidocaine or other numbing agents.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539317

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Martha Goetsch, MD Oregon Health and Science University
  More Information

Additional Information:
No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martha Goetsch, MD, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01539317     History of Changes
Other Study ID Numbers: OHSU IRB 7630
Study First Received: December 21, 2011
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Vulvodynia
Dyspareunia
Breast Cancer
Menopause
Vaginal dryness
Painful intercourse

Additional relevant MeSH terms:
Vulvodynia
Breast Neoplasms
Dyspareunia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vulvar Diseases
Genital Diseases, Female
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014