Trial · NCT00296036
Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
NCT00296036, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer. Trials, record NCT00296036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00296036
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
- NCT number
- NCT00296036
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 137 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- pyridoxine hydrochloride, urea/lactic acid-based topical cream, placebo
- First posted
- 2006-02-24
- Last updated
- 2017-03-16
- Results first posted
- 2017-03-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia | First 3 weeks of treatment | 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. |
| Secondary | To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream | Up to 4, 21-day cycles | 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. |
| Secondary | Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD). | First 3 weeks of treatment | 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. |
| Secondary | Evaluate the Potential Toxicity of Vitamin B6. | up to 4, 21-day cycles | 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. |
| Secondary | 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. | First 3 weeks of treatment | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia | First 3 weeks of treatment | 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). | percentage of participants | NUMBER |
| SECONDARY | To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream | Up to 4, 21-day cycles | All patients that were evaluated for adverse events were included in this analysis. | participants | NUMBER |
| SECONDARY | Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD). | First 3 weeks of treatment | 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. | ||
| SECONDARY | Evaluate the Potential Toxicity of Vitamin B6. | up to 4, 21-day cycles | 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. | ||
| SECONDARY | 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. | First 3 weeks of treatment | 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. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia | Urea/Lactic Acid Cream | 13.6 | percentage of participants | ||
| To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia | Placebo Cream | 10.2 | percentage of participants | ||
| To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream | Urea/Lactic Acid Cream | Grade 3+ Adverse Event | 21 | participants | |
| To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream | Placebo Cream | Grade 3+ Adverse Event | 18 | participants | |
| To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream | Urea/Lactic Acid Cream | Grade 4+ Adverse Event | 3 | participants | |
| To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream | Placebo Cream | Grade 4+ Adverse Event | 3 | participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: (Urea/Lactic Acid +Vit B6) | 19 | |
| Overall Study | STARTED | Arm II: (Urea/Lactic Acid + Placebo) | 18 | |
| Overall Study | STARTED | Arm III: (Placebo +Vit B6) | 18 | |
| Overall Study | STARTED | Arm IV: (Placebo + Placebo) | 17 | |
| Overall Study | STARTED | Arm V: Urea/Lactic Acid | 33 | |
| Overall Study | STARTED | Arm VI: (Placebo) | 32 | |
| Overall Study | COMPLETED | Arm I: (Urea/Lactic Acid +Vit B6) | 18 | |
| Overall Study | COMPLETED | Arm II: (Urea/Lactic Acid + Placebo) | 18 | |
| Overall Study | COMPLETED | Arm III: (Placebo +Vit B6) | 16 | |
| Overall Study | COMPLETED | Arm IV: (Placebo + Placebo) | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | Urea/Lactic Acid Cream | 0 | 67 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo Cream | 1 | 63 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Urea/Lactic Acid Cream | 0 | 67 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Placebo Cream | 1 | 63 | 1 |
| other | Arrhythmia supraventricular | Cardiac disorders | Urea/Lactic Acid Cream | 1 | 67 | 1 |
| other | Arrhythmia supraventricular | Cardiac disorders | Placebo Cream | 0 | 63 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Urea/Lactic Acid Cream | 1 | 67 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Placebo Cream | 0 | 63 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Urea/Lactic Acid Cream | 0 | 67 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo Cream | 2 | 63 | 2 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Urea/Lactic Acid Cream | ||
| Total, all-cause mortality | Placebo Cream | ||
| Total, other adverse events | Urea/Lactic Acid Cream | 56 | 67 |
| Total, other adverse events | Placebo Cream | 50 | 63 |
| Total, serious adverse events | Urea/Lactic Acid Cream | 0 | 67 |
| Total, serious adverse events | Placebo Cream | 0 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21060036 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Urea/Lactic Acid Cream vs Placebo Cream: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00296036
GET https://conductscience.org/api/trials/v1/NCT00296036/events?page=2