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

• Sponsor: Applied Biology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03592121
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 0.2

Study Details

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
• 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: Jul 9, 2018
• Actual Primary Completion Date: Oct 12, 2019
• Actual Study Completion Date: Oct 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 Names: 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 Names: Vehicle Solution

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2017

More Information

Publications

None provided.

• Responsible Party: Applied Biology, Inc.
• ClinicalTrials.gov Identifier: NCT03592121
• Other Study ID Numbers: RJ-101-RCT-001
• First Posted: Jul 19, 2018
• Last Update Posted: Mar 12, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Phenylephrine

Study Results

Participant Flow

Arm/Group Title	AB-101	Placebo
Arm/Group Description	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity
Period Title: Overall Study
STARTED	3	0
COMPLETED	3	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	AB-101	Placebo	Total
Arm/Group Description	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity	Total of all reporting groups
Overall Participants	3	0	3
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	3 100%	0 NaN	3 100%
>=65 years	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	3 100%	0 NaN	3 100%
Male	0 0%	0 NaN	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN
Not Hispanic or Latino	3 100%	3 Infinity
Unknown or Not Reported	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	3 100%	3 Infinity
Delayed Orgasm Grade (CTCAE v4.0) (Grade) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Grade]	0.67 (0.58)	0.67 (0.58)

Outcome Measures

1. Primary Outcome

Title	Change in Delayed Orgasm Grade
Description	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]

Outcome Measure Data

Analysis Population Description

We were unable to recruit a sufficient number of subjects.

Arm/Group Title	AB-101	Placebo
Arm/Group Description	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity
Measure Participants	3	0
Mean (Standard Deviation) [Grade]	-0.33 (0.58)

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	The topical product is used in OTC medications.
Arm/Group Title	AB-101		Placebo
Arm/Group Description	Apply to both nipple/areola regions approximately 1 hour prior to sexual activity AB-101: Apply approximately 1 hour prior to sexual activity		Apply to both nipple/areola regions approximately 1 hour prior to sexual activity Placebo: Apply approximately 1 hour prior to sexual activity
All Cause Mortality
	AB-101		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Serious Adverse Events
	AB-101		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	AB-101		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.