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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: |
NCT01751893 |
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Date of registration:
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14/12/2012 |
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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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Testing the Effectiveness of Henna on Managing PPE
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Scientific title:
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A Randomized Double-blind, Placebo-controlled Study of the Effects of Lawsonia Inermis on Palmar-Plantar Erythrodysesthesia Induced by Capecitabine and/or Pegylated Liposomal Doxorubicin |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01751893 |
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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: Quadruple (Participant, Care Provider, 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 natural henna.
- Patients with pre-existing dermatological condition affecting the hands or feet that
may limit the interpretation of results
- Patients on 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 (PPE)
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Intervention(s)
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Drug: Henna
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Drug: Placebo
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Primary Outcome(s)
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Change from Baseline PPE Grade at 3,4, 5,6 weeks
[Time Frame: 3, 4, 5 and 6 weeks]
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Secondary Outcome(s)
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Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks
[Time Frame: 3, 4, 5 and 6 weeks]
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Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks
[Time Frame: 3, 4,5 and 6 weeks]
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Secondary ID(s)
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AC-PPEHP-88
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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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