Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer
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|ClinicalTrials.gov Identifier: NCT00003097|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 2, 2004
Last Update Posted : February 9, 2009
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 or disease||Intervention/treatment||Phase|
|Non-Melanomatous Skin Cancer||Other: preventative dietary intervention||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Official Title:||Skin Cancer Prophylaxis by Low-Fat Dietary Intervention|
|Study Start Date :||April 1989|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003097
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Study Chair:||Homer Black, PhD||Baylor College of Medicine|