Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer - Full Text View

Sponsors and Collaborators:	Baylor College of Medicine National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003097

Purpose

RATIONALE: A low-fat, balanced diet may prevent disease progression in patients with nonmelanomatous skin cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of a low-fat, balanced diet to prevent disease progression in patients with nonmelanomatous skin cancer.

Condition	Intervention	Phase
Non-Melanomatous Skin Cancer	Other: preventative dietary intervention	Phase II

Study Type:	Interventional
Study Design:	Prevention
Official Title:	Skin Cancer Prophylaxis by Low-Fat Dietary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diets Skin Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	175
Study Start Date:	April 1989

Detailed Description:

OBJECTIVES: I. Determine whether intervention with a low-fat balanced diet will prolong the disease-free survival time in patients presenting with nonmelanomatous skin cancer and having a history of not more than two previous skin cancers. II. Assess the effect of this intervention on numbers of tumors during the two year follow-up period. III. Determine the incidence of new skin cancer in the control, nonintervention population.

OUTLINE: This is a randomized study. Patients are randomized into the Dietary Intervention or Nonintervention groups. The control group has initial and follow up assessment of eating habits. The dietary intervention group also has initial and follow up assessment of eating habits that have been changed to reduce fat intake to one-half of the amount in the average American diet with a subsequent increase of carbohydrates to compensate for total caloric intake. Both groups have assessment of clinical status of skin cancer at 4 month intervals for 24 months. Patients are followed for two years.

PROJECTED ACCRUAL: Approximately 175 patients will be accrued in the first 3 years of this study.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed basal cell carcinoma or squamous cell carcinoma of the skin No more than two prior skin carcinomas Must not have genetic predisposition to skin cancer (i.e., xeroderma pigmentosum, basal cell nevous syndrome)

PATIENT CHARACTERISTICS: Age: 15 and over Race: Caucasian Performance status: Not specified Life expectancy:

Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No therapeutic diet that requires fat intake greater than 20% of total calories No untreated systemic malignancy No history of arsenic ingestion Not diabetic

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent systemic steroids Radiotherapy: No prior x-ray therapy for acne No prior/concurrent ultraviolet light (PUVA or UVB) therapy for psoriasis Surgery: Not specified Other: No concurrent megavitamin or mineral supplementation At least 5 years since treatment with antimetabolites, folic acid inhibitors, alkalating agents, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003097

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Homer Black, PhD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Black HS, Wolf JE: Protective influence of a low-fat diet on non-melanoma skin cancer. Dermatologic Therapy: Phototherapy and Photoprotective Therapy 4: 100-105, 1997.

Black HS, Wolf JE: A low-fat diet can reduce skin cancer risk. Primary Care and Cancer 15: 12-13, 1996.

Black HS: Low-fat diet impedes the development of actinic keratosis. Biomedical Pharmacotherapy 49: 46-47, 1995.

Black HS, Thornby JI, Wolf JE Jr, Goldberg LH, Herd JA, Rosen T, Bruce S, Tschen JA, Scott LW, Jaax S, et al. Evidence that a low-fat diet reduces the occurrence of non-melanoma skin cancer. Int J Cancer. 1995 Jul 17;62(2):165-9.

Black HS, Wolk JE Jr: A low-fat diet can reduce skin cancer risk. Skin Cancer Foundation Journal 13: 37/98, 1995.

Black HS, Herd JA, Goldberg LH, Wolf JE Jr, Thornby JI, Rosen T, Bruce S, Tschen JA, Foreyt JP, Scott LW, et al. Effect of a low-fat diet on the incidence of actinic keratosis. N Engl J Med. 1994 May 5;330(18):1272-5.

Black HS, Jaax S: Low-Fat Dietary Guide to Aid in the Management of Skin Cancer. Houston, TX: 1999.

Black HS. Influence of dietary factors on actinically-induced skin cancer. Mutat Res. 1998 Nov 9;422(1):185-90. Review.

Black HS: Diet and skin cancer. In: Heber D, Blackburn GL, Go VL: Nutritional Oncology. San Diego, CA: Academic Press, 1999, pp. 405-419.

Jaax S, Scott LW, Wolf JE Jr, Thornby JI, Black HS. General guidelines for a low-fat diet effective in the management and prevention of nonmelanoma skin cancer. Nutr Cancer. 1997;27(2):150-6.

Study ID Numbers:	CDR0000065820, BCM-H-109, NCI-P97-0105
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003097 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

basal cell carcinoma of the skin
squamous cell carcinoma of the skin

Study placed in the following topic categories:

Skin Diseases
Epidermoid Carcinoma
Disease Progression
Carcinoma, Basal Cell

Squamous Cell Carcinoma
Skin Neoplasms
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Skin Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009