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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01867294
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization
* Ability to reliably apply topical spironolactone/placebo twice a day to the face
* Ability to complete questionnaire(s) by themselves or with assistance
* For study 2 only, patients must be willing to avoid sun exposure for one month from registration
* Creatinine =\< 1.5 x upper limit of normal (UNL)
* For Study 2 only, ability to apply topical creams to the entire face and body
Exclusion Criteria:
* Prior allergic reaction or severe intolerance to spironolactone
* Any rash at the time of randomization
* Cutaneous metastases
* Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist
* Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol)
* For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01867294
Study Brief:
Protocol Section:
NCT01867294