Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer
NCT ID: NCT00003097
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
175 participants
INTERVENTIONAL
1989-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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PREVENTION
Interventions
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preventative dietary intervention
Eligibility Criteria
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Inclusion Criteria
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.
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Baylor College of Medicine
OTHER
Principal Investigators
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Homer Black, PhD
Role: STUDY_CHAIR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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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. doi: 10.1016/s0027-5107(98)00191-2.
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. doi: 10.1080/01635589709514517.
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. doi: 10.1002/ijc.2910620210.
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. doi: 10.1056/NEJM199405053301804.
Other Identifiers
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BCM-H-109
Identifier Type: -
Identifier Source: secondary_id
NCI-P97-0105
Identifier Type: -
Identifier Source: secondary_id
CDR0000065820
Identifier Type: -
Identifier Source: org_study_id
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