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Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer

Primary Purpose

Non-Melanomatous Skin Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
preventative dietary intervention
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 6, 2009
Sponsor
Baylor College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003097
Brief Title
Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer
Official Title
Skin Cancer Prophylaxis by Low-Fat Dietary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 1989 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baylor College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Melanomatous Skin Cancer
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
preventative dietary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Homer Black, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Black HS, Jaax S: Low-Fat Dietary Guide to Aid in the Management of Skin Cancer. Houston, TX: 1999.
Results Reference
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PubMed Identifier
9920444
Citation
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.
Results Reference
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Citation
Black HS: Diet and skin cancer. In: Heber D, Blackburn GL, Go VL: Nutritional Oncology. San Diego, CA: Academic Press, 1999, pp. 405-419.
Results Reference
background
PubMed Identifier
9121942
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
Black HS, Wolf JE: A low-fat diet can reduce skin cancer risk. Primary Care and Cancer 15: 12-13, 1996.
Results Reference
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Citation
Black HS: Low-fat diet impedes the development of actinic keratosis. Biomedical Pharmacotherapy 49: 46-47, 1995.
Results Reference
result
PubMed Identifier
7622291
Citation
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.
Results Reference
result
Citation
Black HS, Wolk JE Jr: A low-fat diet can reduce skin cancer risk. Skin Cancer Foundation Journal 13: 37/98, 1995.
Results Reference
result
PubMed Identifier
8145782
Citation
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.
Results Reference
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Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer

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