Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445250
Status:
UNKNOWN
Last Update Posted:
2007-03-08
First Post:
2007-03-07
Brief Title:
The Role of Calcipotriol as Radioprotector of Skin
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
NOT_YET_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:
Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast
To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus use of medications allergies weight habits size of the irradiated breast previous chemotherapy treatment and exposure to sunlight
To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus use of medications allergies weight habits size of the irradiated breast previous chemotherapy treatment and exposure to sunlight
Detailed Description:
STUDY PROTOCOL
Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy will participate in the study About 15 minutes after receiving the daily radiation dose fraction a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse The other half of the breast will have a standard cream applied During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy eg strong erythema painful tenderness etcThe adverse skin effects will be assessed according to the following criteria
1 an assessment by a physician and a nurse according to the RTOG score 6
As follows
Grade 0 - no reaction Grade 1 - light erythema dry peeling decrease in sweat production Grade 3 - extensive moist peeling pitting edema Grade 4 - ulcers bleeding and necrosis
2 A questionnaire to each patient regarding the efficacy and safety of the cream
3 Number of interruption of radiotherapy treatment The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment
Safety report will be sent to the local independent ethics committee after the examination of the first ten patients
The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above The relation between the background disease medications allergies weight habits size of the irradiated breast sun exposure previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated
INCLUSION CRITERIA
1 Age ranging from 18 to 75
2 Confirmed histological diagnosis of Breast cancer
3 Radiotherapy treatment to the breast following lumpectomy
EXCLUSION CRITERIA
1 Scleroderma
2 An extremely large breast Interfiled above 25 cm
3 Prior radiotherapy to the same breast radiotherapy to the contra lateral breast is not a contraindication
4 Mastectomy
Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy will participate in the study About 15 minutes after receiving the daily radiation dose fraction a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse The other half of the breast will have a standard cream applied During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy eg strong erythema painful tenderness etcThe adverse skin effects will be assessed according to the following criteria
1 an assessment by a physician and a nurse according to the RTOG score 6
As follows
Grade 0 - no reaction Grade 1 - light erythema dry peeling decrease in sweat production Grade 3 - extensive moist peeling pitting edema Grade 4 - ulcers bleeding and necrosis
2 A questionnaire to each patient regarding the efficacy and safety of the cream
3 Number of interruption of radiotherapy treatment The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment
Safety report will be sent to the local independent ethics committee after the examination of the first ten patients
The protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above The relation between the background disease medications allergies weight habits size of the irradiated breast sun exposure previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated
INCLUSION CRITERIA
1 Age ranging from 18 to 75
2 Confirmed histological diagnosis of Breast cancer
3 Radiotherapy treatment to the breast following lumpectomy
EXCLUSION CRITERIA
1 Scleroderma
2 An extremely large breast Interfiled above 25 cm
3 Prior radiotherapy to the same breast radiotherapy to the contra lateral breast is not a contraindication
4 Mastectomy
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