Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003097
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Low Fat Diet to Prevent Disease Progression in Patients With Skin Cancer
Sponsor:
Baylor College of Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Skin Cancer Prophylaxis by Low-Fat Dietary Intervention
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P97-0105 | None | None | None |
| BCM-H-109 | None | None | None |