A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors

• Status: Withdrawn
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposal describes a pilot study to gather preliminary evidence of efficacy, tolerability and toxicity of oral PLE among a high-risk skin cancer population for the prevention of Actinic keratosis (AKs) and keratinocytes (KCs) to gain insight into optimal methods for recruitment, intervention development, data collection, and promoting protocol adherence prior to conducting a fully powered trial. The primary clinical outcome is AKs as measured by a clinical dermatologist, with skin cancer as a secondary clinical outcome. The investigators will also assess histologic markers of Ultra Violet (UV) damage, which have previously been shown to be reduced with oral PLE use in human studies, namely formation of UV-induced cyclo pyrimidine dimer positive cells and number of sunburn cells among epidermal keratinocytes. Results generated from this proposal will form the foundation of a fully powered clinical trial of the effect of PLE on the risk of AKs and KCs. The results may also provide information about this promising dietary supplement which may provide extra protection for a high-risk skin cancer population.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

• Must be male or female and at least 18 years of age.

• Female patients must be of:

• Non-childbearing potential;

• Childbearing potential, provided negative urine pregnancy test and using effective contraception.

• Dermatologist-rendered diagnosis of AK in the past 2 years.

Exclusion Criteria:

• History of >2 skin cancers in the past 5 years

• History of dementia

• Cardiovascular disease, defined as Blood Pressure (BP) <90/60 or Heart rate (HR) >110 in the past year or a history of myocardial infection

• Inflammatory bowel disease/irritable bowel syndrome

• Treatment with Fluorouracil, imiquimod, diclofenac, or photodynamic therapy in the past 8 weeks

• Intention to seek more aggressive AK therapy such as photodynamic therapy, laser surgery in next 12 months

• Serious psychological illness

• History of alcohol or drug abuse

• Any disease or condition which would interfere with study participation or unduly increase risk.