Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Nu Skin Enterprises
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00836342

Purpose

The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.

Condition
Skin Cancer Basal Cell Carcinoma Squamous Cell Carcinoma

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	Comparison of Skin Carotenoid Levels Between Subjects With History of Cutaneous Squamous Cell Carcinoma and Subjects With History of Basal Cell Carcinoma Versus a Control Group

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer

Drug Information available for: Carotenoids

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Skin carotenoid levels in subjects with history of squamous cell carcinoma versus control subjects [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Skin carotenoid levels in subjects with history of squamous cell carcinoma versus subjects with history of basal cell carcinoma [ Time Frame: baseline ] [ Designated as safety issue: No ]
Skin carotenoid levels in subjects with history of basal cell carcinoma versus control group [ Time Frame: baseline ] [ Designated as safety issue: No ]
Evaluate the relationship between demographics and history of non-melanoma skin cancers and the levels of skin carotenoids [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Previous history of SCC
2 Previous history of BCC
3 Control

Detailed Description:

There has been experimental and clinical research evaluating association of different carotenoids and incidence of malignancies, including Non- Melanoma Skin Cancer (NMSC). An easy and inexpensive way to determine which subjects would benefit from supplementation with carotenoids or retinoids could be the measurement of skin carotenoid levels.The least invasive way to perform it is through Raman spectroscopy which is a technique that uses a laser light that can be used to quantify carotenoids on the skin. We will compare the skin carotenoid levels of subjects with previous history of SCC or BCC and subjects without history of previous NMSC.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

The research population will be recruited from Massachusetts General Hospital dermatology clinics.

Criteria

Inclusion Criteria:

Subjects between 50 and 75 years old without history of previous SCC or BCC.
Fitzpatrick skin types I-IV.
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures

Exclusion Criteria:

Regular ingestion of supplements containing carotenoids or vitamin A in the past 4 weeks.
Use of topical retinoids in the past 4 weeks.
Treatment with systemic retinoids in the past 6 months.
Dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, palmar psoriasis, hand dermatitis or palmo-plantar keratoderma.
Previous history of psoriasis.
Clinically significant abnormal findings or conditions, which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Subjects who are known to be pregnant or planning a pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836342

Contacts

Contact: Lynne H Hermosilla

617-726-5066

harvardskinstudies@partners.org

Locations

United States, Massachusetts
Clinical Unit for Research Trials in Skin - MGH	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Xinaida Lima 617-726-5066
Principal Investigator: Alexandra B Kimball, MD, MPH
Sub-Investigator: Maria B Alora-Palli, MD

Sponsors and Collaborators

Massachusetts General Hospital

Nu Skin Enterprises

Investigators

Principal Investigator:

Alexandra B Kimball, MD, MPH

Massachusetts General Hospital

More Information

Publications:

Bath-Hextall F, Leonardi-Bee J, Somchand N, Webster A, Delitt J, Perkins W. Interventions for preventing non-melanoma skin cancers in high-risk groups. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005414. Review.

Santamaria L, Bianchi A. Cancer chemoprevention by supplemental carotenoids in animals and humans. Prev Med. 1989 Sep;18(5):603-23. Review.

Heinen MM, Hughes MC, Ibiebele TI, Marks GC, Green AC, van der Pols JC. Intake of antioxidant nutrients and the risk of skin cancer. Eur J Cancer. 2007 Dec;43(18):2707-16. Epub 2007 Nov 7.

Frieling UM, Schaumberg DA, Kupper TS, Muntwyler J, Hennekens CH. A randomized, 12-year primary-prevention trial of beta carotene supplementation for nonmelanoma skin cancer in the physician's health study. Arch Dermatol. 2000 Feb;136(2):179-84.

Ermakov IV, Ermakova MR, McClane RW, Gellermann W. Resonance Raman detection of carotenoid antioxidants in living human tissues. Opt Lett. 2001 Aug 1;26(15):1179-81.

Responsible Party:	Alexandra Boer Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00836342 History of Changes
Other Study ID Numbers:	2008-P-002240
Study First Received:	February 2, 2009
Last Updated:	March 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Non-melanoma skin cancer
Basal cell carcinoma
Squamous cell carcinoma

Additional relevant MeSH terms:

Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases

Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012