Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01097850
Eligibility Criteria:
Inclusion Criteria:
* Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
* New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
* Patients must be 18 years or older
* Patients must provide written informed consent to participate in the study
Exclusion Criteria:
* Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
* Known allergy to natural henna
* Patients with a previous history of HFS
* History of G6PD deficiency as determined by screening bloodwork
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01097850
Study Brief:
Protocol Section:
NCT01097850