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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02625415 |
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Date of registration:
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05/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia
HFSB6 |
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Scientific title:
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A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02625415 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Cyprus
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult cancer patients (>18)
- Patients receiving capecitabine and/or PLD as monotherapy or in combination with other
agents
- Patients that will experience PPE grade 1 or above
- Willing to participate
- Ability to complete the psychometric assessments.
- A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG
Exclusion Criteria:
- Patients with hypersensitivity to Vitamin B.
- Patients with pre-existing dermatological condition affecting the hands or/and feet
that may limit the interpretation of results
- Patients on oral Pyridoxine or nicotine patches
- Patients with a previous history of PPE
- Patients whose chemotherapy was discontinued for more than a week
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Palmar-Plantar Erythrodysesthesia
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Intervention(s)
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Device: Placebo Vitamin B6 cream
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Device: Vitamin B6 cream
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Primary Outcome(s)
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PPE grade
[Time Frame: up to 4 weeks]
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Secondary Outcome(s)
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Health Related Quality of Life
[Time Frame: up to 4 weeks]
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Quality of Life in relation to PPE
[Time Frame: up to 4 weeks]
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Secondary ID(s)
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AC-PPEHP-89
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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