Breast Cancer, Cancer of Breast, Neuropathy, Nipple Disorder, Sexual Arousal Disorder, Sexual Dysfunction, Sexual Dysfunction, Physiological
Conditions
Keywords
Nipple Neuropathy, Cancer Survivor
Brief summary
The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.
Detailed description
Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life. Currently, there are no treatments for restoring nipple sensitivity and the associatedto improve lower sexual quality of life this condition. It would thus be of great clinical benefit to post breast surgery patients if a provide a new safe and , effective , topical , on-demand, treatment for this condition can be developed.
Interventions
DRUGAB-101
Apply approximately 1 hour prior to sexual activity
DRUGPlacebo
Apply approximately 1 hour prior to sexual activity
Sponsors
Applied Biology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female breast cancer survivor * Age: 18 to 70 * First diagnosed with Stage I or II breast cancer * Have had breast surgery: nipple sparring mastectomy or lumpectomy * At least 3 years post surgery * Nipple neuropathy post breast surgery (change in Llikeart scale \>= 3 between pre and post surgery) * Baseline nipple sensitivity \<=5 (likeartLikert scale) * QoL-BC (\>=7) * Delayed orgasm (CTCAE v4.0) Grade 2 * One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3 * Able to give informed consent * Currently in a monogamous heterosexual relationship for at least 12 months * Sexually active within the last 30 days * Willing to engage in sexual activity at least once a month during the duration of the study * Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet * Willing to use an adequate method of birth control * Able to comply with the study requirements for 8 consecutive weeks * Able to give informed consent
Exclusion criteria
* Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class * Currently pregnant * Nursing within the last 6 months prior to beginning the study * History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery * Actively being treated for breast cancer * Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months * Uncontrolled or severe hypertension * Decreased oxygen in the tissues or blood * Active inflammation of the liver * Acute inflammation of the pancreas * Overactive thyroid gland * Acidosis * Diabetes * Spinal cord injury * Nipple dermatitis * Regional complex pain syndrome * Use of any hypertensive drugs * Use of MAO inhibitors * Subjects assigned to interventional drug arm and failed to report an increase \>=2 from baseline in nipple sensitivity (likert scale) during phase I * In partners: sexual dysfunction or erectile dysfunction * Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days * Nipple dermatitis * Regional complex pain syndrome * Unable to provide consent or make allotted clinical visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Delayed Orgasm Grade | [baseline, week 8] | Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0 Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax. This is a binary grading system: Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AB-101 Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
AB-101: Apply approximately 1 hour prior to sexual activity | 3 |
| Placebo Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Placebo: Apply approximately 1 hour prior to sexual activity | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | AB-101 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Delayed Orgasm Grade (CTCAE v4.0) | 0.67 Grade STANDARD_DEVIATION 0.58 | — | 0.67 Grade STANDARD_DEVIATION 0.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | — | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | — | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | — | 0 Participants |
| Region of Enrollment United States | 3 participants | — | 3 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Change in Delayed Orgasm Grade
Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0 Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax. This is a binary grading system: Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship
Time frame: [baseline, week 8]
Population: We were unable to recruit a sufficient number of subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AB-101 | Change in Delayed Orgasm Grade | -0.33 Grade | Standard Deviation 0.58 |