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: April 8, 2014
Last verified: April 2014

December 21, 2011
April 8, 2014
December 2011
November 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01539317 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

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.

Subjects will be recruited primarily through provider referrals from Oncology, Center for Women's Health, and The Breast Imaging Center. The Women's Health Research Unit will also recruit by using print ads and craigslist.

For this study there will be three visits over a 5 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 16 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Vulvodynia
  • Dyspareunia
  • Breast Cancer
  • Menopause
Drug: Topical liquid lidocaine
Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
  • Placebo Comparator: Topical liquid lidocaine
    Intervention: Drug: Topical liquid lidocaine
  • Placebo Comparator: Topical Saline
    Intervention: Drug: Topical liquid lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Women aged 18 to 65 years old.
  2. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
  3. 2 years 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. At least 2 years of menopause, demonstrated by at least one of the following:

    • cessation of menses for 2 years
    • Bilateral oophorectomy
    • 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.

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.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01539317
OHSU IRB 7630
Yes
Martha Goetsch, MD, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Martha Goetsch, MD Oregon Health and Science University
Oregon Health and Science University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP