Study to Investigate the Effect of AB-101 in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Study to Investigate the Effect of AB-101 in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592121
• Other study ID #: RJ-101-RCT-001
• Status: Completed
• Phase: Early Phase 1
• Start date: July 9, 2018
• Est. completion date: October 12, 2019

Study information

• Verified date: February 2020
• Source: Applied Biology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 12, 2019
• Est. primary completion date: October 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of Breast
• Disease
• Neuropathy
• Nipple Disorder
• Sexual Arousal Disorder
• Sexual Dysfunction
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• AB-101
Apply approximately 1 hour prior to sexual activity
• Placebo
Apply approximately 1 hour prior to sexual activity

Locations

Country	Name	City	State
United States	Southern CA Center for Sexual Health and Survivorship Medicine	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Applied Biology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	[baseline, week 8]