Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296036
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2006-02-23
Brief Title:
Pyridoxine and Topical UreaLactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Placebo-controlled Double-blind Trial to Determine the Effectiveness of a UreaLactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
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 Pyridoxine vitamin B6 and topical urealactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy It is not yet known whether giving pyridoxine with or without topical urealactic acid-based cream is more effective than topical urealactic acid-based cream alone or a placebo in preventing hand-foot syndrome
PURPOSE This randomized phase III trial is studying pyridoxine and topical urealactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo giving topical urealactic acid-based cream together with a placebo or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer
PURPOSE This randomized phase III trial is studying pyridoxine and topical urealactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo giving topical urealactic acid-based cream together with a placebo or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer
Detailed Description:
OBJECTIVES
Determine whether the prophylactic use of a topical urealactic acid cream can decrease the incidenceseverity of capecitabine-caused palmar-plantar erythrodysesthesia in patients receiving capecitabine for breast andor other cancer
Evaluate the potential toxicity of this cream
Determine whether the prophylactic use of vitamin B6 can decrease the incidence andor severity of capecitabine-caused palmar-plantar erythrodysesthesia
Evaluate the potential toxicity of vitamin B6
Determine whether the prophylactic use of a topical urealactic acid cream in combination with vitamin B6 can decrease the incidence andor severity of capecitabine caused palmar-plantar erythrodysesthesia
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to age 50 years old vs 50-60 years old vs 60 years old sex capecitabine dose level 2000 mgday vs 2500 mgday cancer type breast vs other and mode of therapy adjuvant including neo-adjuvant therapy vs metastatic disease Patients are randomized to 1 of 6 treatment arms treatment arms I-IV closed to accrual as of 1024007
Arm I closed to accrual as of 10242007 Patients receive topical urealactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21
Arm II closed to accrual as of 10242007 Patients receive topical urealactic acid-based cream as in arm I closed to accrual as of 10242007 and oral placebo once daily on days 1-21
Arm III closed to accrual as of 10242007 Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I closed to accrual as of 10242007
Arm IV closed to accrual as of 10242007Patients receive placebo cream as in arm III and oral placebo as in arm II closed to accrual as of 10242007
Arm V Patients receive topical urealactic acid-based cream applied to palms and soles twice daily on days 1-21
Arm VI Patients receive placebo cream applied to palms and soles twice daily on days 1-21
In all arms treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Determine whether the prophylactic use of a topical urealactic acid cream can decrease the incidenceseverity of capecitabine-caused palmar-plantar erythrodysesthesia in patients receiving capecitabine for breast andor other cancer
Evaluate the potential toxicity of this cream
Determine whether the prophylactic use of vitamin B6 can decrease the incidence andor severity of capecitabine-caused palmar-plantar erythrodysesthesia
Evaluate the potential toxicity of vitamin B6
Determine whether the prophylactic use of a topical urealactic acid cream in combination with vitamin B6 can decrease the incidence andor severity of capecitabine caused palmar-plantar erythrodysesthesia
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to age 50 years old vs 50-60 years old vs 60 years old sex capecitabine dose level 2000 mgday vs 2500 mgday cancer type breast vs other and mode of therapy adjuvant including neo-adjuvant therapy vs metastatic disease Patients are randomized to 1 of 6 treatment arms treatment arms I-IV closed to accrual as of 1024007
Arm I closed to accrual as of 10242007 Patients receive topical urealactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21
Arm II closed to accrual as of 10242007 Patients receive topical urealactic acid-based cream as in arm I closed to accrual as of 10242007 and oral placebo once daily on days 1-21
Arm III closed to accrual as of 10242007 Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I closed to accrual as of 10242007
Arm IV closed to accrual as of 10242007Patients receive placebo cream as in arm III and oral placebo as in arm II closed to accrual as of 10242007
Arm V Patients receive topical urealactic acid-based cream applied to palms and soles twice daily on days 1-21
Arm VI Patients receive placebo cream applied to palms and soles twice daily on days 1-21
In all arms treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000464246 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2009-00655 | REGISTRY | None | None |
| ROCHE-NCCTG-N05C5 | None | None | None |