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

• ClinicalTrials.gov Identifier: NCT03592121
• Recruitment Status: Completed
• First Posted: July 19, 2018
• Results First Posted: March 12, 2020
• Last Update Posted: March 12, 2020
• Sponsor: Applied Biology, Inc.
• Information provided by (Responsible Party): Applied Biology, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sexual Dysfunction; Sexual Arousal Disorder; Sexual Dysfunction, Physiological; Breast Cancer; Nipple Disorder; Neuropathy; Cancer of Breast	Drug: AB-101; Drug: Placebo	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
• Actual Study Start Date: July 9, 2018
• Actual Primary Completion Date: October 12, 2019
• Actual Study Completion Date: October 12, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: AB-101; Apply to both nipple/areola regions approximately 1 hour prior to sexual activity	Drug: AB-101; Apply approximately 1 hour prior to sexual activity; Other Name: Phenylephrine
Placebo Comparator: Placebo; Apply to both nipple/areola regions approximately 1 hour prior to sexual activity	Drug: Placebo; Apply approximately 1 hour prior to sexual activity; Other Name: Vehicle Solution

Outcome Measures

Primary Outcome Measures :

1. Change in Delayed Orgasm Grade [ Time Frame: [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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female Breast Cancer Survivors
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Southern CA Center for Sexual Health and Survivorship Medicine

Newport Beach, California, United States, 92663

Sponsors and Collaborators

Applied Biology, Inc.

Investigators

• Principal Investigator: Michael Krychman, MD; Southern CA Center for Sexual Health and Survivorship Medicine

  Study Documents (Full-Text)

Documents provided by Applied Biology, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] September 7, 2017

More Information

• Responsible Party: Applied Biology, Inc.
• ClinicalTrials.gov Identifier: NCT03592121
• Other Study ID Numbers: RJ-101-RCT-001
• First Posted: July 19, 2018
• Results First Posted: March 12, 2020
• Last Update Posted: March 12, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Applied Biology, Inc.:

Nipple Neuropathy, Cancer Survivor

Additional relevant MeSH terms:

Breast Neoplasms; Sexual Dysfunction, Physiological; Disease; Sexual Dysfunctions, Psychological; Pathologic Processes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Mental Disorders; Phenylephrine; Cardiotonic Agents; Mydriatics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Respiratory System Agents; Adrenergic alpha-1 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents