Breast Cancer Clinical Trial
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Newport Beach California, 92663, United States
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