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Trial record 28 of 230 for:    pyridoxine

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

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ClinicalTrials.gov Identifier: NCT00296036
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Dietary Supplement: pyridoxine hydrochloride
Drug: urea/lactic acid-based topical cream
Other: placebo
Enrollment 137
Recruitment Details  
Pre-assignment Details This trial was originally designed as a two-by-two factorial trial to test if urea/lactic acid–based cream and/or oral pyridoxine (B6) could decrease capecitabine-caused HFS. After results from another study found B6 and capecitabine combination ineffective in preventing HFS, the study was amended to a two-arm, randomized clinical trial.
Arm/Group Title Arm I: (Urea/Lactic Acid +Vit B6) Arm II: (Urea/Lactic Acid + Placebo) Arm III: (Placebo +Vit B6) Arm IV: (Placebo + Placebo) Arm V: Urea/Lactic Acid Arm VI: (Placebo)
Hide Arm/Group Description Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21. Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21. Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I Patients receive placebo cream and oral placebo. Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21. Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
Period Title: Overall Study
Started 19 18 18 17 33 32
Completed 18 18 16 16 31 28
Not Completed 1 0 2 1 2 4
Reason Not Completed
Withdrawal by Subject             1             0             2             1             2             1
Protocol Violation             0             0             0             0             0             3
Arm/Group Title Urea/Lactic Acid Cream Placebo Cream Total
Hide Arm/Group Description Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21. Patients receive placebo cream applied to palms and soles twice daily on days 1-21. Total of all reporting groups
Overall Number of Baseline Participants 67 60 127
Hide Baseline Analysis Population Description
Arms I (18), II (18), and IV (31) were combined and analyzed as patients treated with Urea/Lactic Acid Cream. Arms III (16), IV (16), and VI (28) were combined as patients treated with placebo in place of Urea/Lactic Acid Cream.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 60 participants 127 participants
<50 11 9 20
50-60 19 17 36
> 60 37 34 71
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 60 participants 127 participants
Female
52
  77.6%
49
  81.7%
101
  79.5%
Male
15
  22.4%
11
  18.3%
26
  20.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants 60 participants 127 participants
67 60 127
1.Primary Outcome
Title To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia
Hide Description A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.
Time Frame First 3 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eight patients from the Urea/Lactic Acid group were not included in the primary analysis (1 did not fill out the diary, 1 refused treatment, 3 had adverse events before completing the diary, and 3 for other reasons). For the placebo arm, 11 were excluded (2 refused further treatment, 2 had adverse events, and 7 went off for other reasons).
Arm/Group Title Urea/Lactic Acid Cream Placebo Cream
Hide Arm/Group Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
Patients receive placebo cream applied to palms and soles twice daily.
Overall Number of Participants Analyzed 59 49
Measure Type: Number
Unit of Measure: percentage of participants
13.6 10.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Urea/Lactic Acid Cream, Placebo Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.768
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream
Hide Description Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time Frame Up to 4, 21-day cycles
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that were evaluated for adverse events were included in this analysis.
Arm/Group Title Urea/Lactic Acid Cream Placebo Cream
Hide Arm/Group Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
Patients receive placebo cream applied to palms and soles twice daily.
Overall Number of Participants Analyzed 67 63
Measure Type: Number
Unit of Measure: participants
Grade 3+ Adverse Event 21 18
Grade 4+ Adverse Event 3 3
3.Secondary Outcome
Title Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).
Hide Description A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.
Time Frame First 3 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.
Arm/Group Title Arm I: (Urea/Lactic Acid +Vit B6) Arm II: (Urea/Lactic Acid + Placebo) Arm III: (Placebo +Vit B6) Arm IV: (Placebo + Placebo) Arm V: Urea/Lactic Acid Arm VI: (Placebo)
Hide Arm/Group Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
Patients receive placebo cream and oral placebo.
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Evaluate the Potential Toxicity of Vitamin B6.
Hide Description Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time Frame up to 4, 21-day cycles
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.
Arm/Group Title Arm I: (Urea/Lactic Acid +Vit B6) Arm II: (Urea/Lactic Acid + Placebo) Arm III: (Placebo +Vit B6) Arm IV: (Placebo + Placebo) Arm V: Urea/Lactic Acid Arm VI: (Placebo)
Hide Arm/Group Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.
Patients receive placebo cream as in arm III and oral placebo as in arm II.
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.
Hide Description A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.
Time Frame First 3 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.
Arm/Group Title Arm I: (Urea/Lactic Acid +Vit B6) Arm II: (Urea/Lactic Acid + Placebo) Arm III: (Placebo +Vit B6) Arm IV: (Placebo + Placebo) Arm V: Urea/Lactic Acid Arm VI: (Placebo)
Hide Arm/Group Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.

Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.

urea/lactic acid-based topical cream: Applied topically

placebo: Given orally or applied topically

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Urea/Lactic Acid Cream Placebo Cream
Hide Arm/Group Description Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21. Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
All-Cause Mortality
Urea/Lactic Acid Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Urea/Lactic Acid Cream Placebo Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      0/63 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Urea/Lactic Acid Cream Placebo Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/67 (83.58%)      50/63 (79.37%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Hemoglobin decreased  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Cardiac disorders     
Arrhythmia supraventricular  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Atrial fibrillation  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/67 (0.00%)  0 2/63 (3.17%)  2
Ascites  1  0/67 (0.00%)  0 2/63 (3.17%)  2
Constipation  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Diarrhea  1  26/67 (38.81%)  39 27/63 (42.86%)  44
Ear, nose and throat examination abnormal  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Lower gastrointestinal hemorrhage  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Mucositis oral  1  1/67 (1.49%)  1 3/63 (4.76%)  3
Nausea  1  4/67 (5.97%)  4 2/63 (3.17%)  2
Vomiting  1  1/67 (1.49%)  1 4/63 (6.35%)  4
General disorders     
Chest pain  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Death NOS  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Disease progression  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Fatigue  1  4/67 (5.97%)  7 5/63 (7.94%)  6
Multi-organ failure  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Infections and infestations     
Pharyngitis  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Investigations     
Alanine aminotransferase increased  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Aspartate aminotransferase increased  1  0/67 (0.00%)  0 2/63 (3.17%)  2
Coagulopathy  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Electrocardiogram QTc interval prolonged  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Leukocyte count decreased  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Neutrophil count decreased  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Platelet count decreased  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Metabolism and nutrition disorders     
Anorexia  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Dehydration  1  6/67 (8.96%)  6 5/63 (7.94%)  6
Serum albumin decreased  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Serum calcium decreased  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Serum potassium decreased  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Serum sodium decreased  1  1/67 (1.49%)  2 1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/67 (1.49%)  3 1/63 (1.59%)  3
Bone pain  1  2/67 (2.99%)  2 0/63 (0.00%)  0
Muscle weakness  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Muscle weakness lower limb  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Muscle weakness upper limb  1  1/67 (1.49%)  1 0/63 (0.00%)  0
Nervous system disorders     
Peripheral motor neuropathy  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Peripheral sensory neuropathy  1  0/67 (0.00%)  0 2/63 (3.17%)  2
Psychiatric disorders     
Confusion  1  2/67 (2.99%)  2 0/63 (0.00%)  0
Renal and urinary disorders     
Urinary incontinence  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/67 (1.49%)  1 1/63 (1.59%)  2
Pleural effusion  1  1/67 (1.49%)  1 1/63 (1.59%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  0/67 (0.00%)  0 1/63 (1.59%)  1
Hand-and-foot syndrome  1  43/67 (64.18%)  91 34/63 (53.97%)  60
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Lawrence Loprinzi, M.D.
Organization: Mayo Clinic
EMail: cloprinzi@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00296036     History of Changes
Other Study ID Numbers: NCCTG-N05C5
NCI-2009-00655 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
ROCHE-NCCTG-N05C5
CDR0000464246 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: February 23, 2006
First Posted: February 24, 2006
Results First Submitted: January 23, 2017
Results First Posted: March 16, 2017
Last Update Posted: March 16, 2017