| Title |
A Randomized Control Trial to Compare Doxycycline to Isotretinoin for the Treatment of Acneiform Eruptions in Cancer Patients on Tyrosine Kinase Inhibitors |
| Protocole ID |
2021-2635 |
| ClinicalTrials.gov ID |
NCT04864717 |
| Cancer Type(s) |
Symptoms Management |
| Phase |
Phase IV |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Doxycycline versus Isotretinoin |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| City |
|
| Principal Investigator |
Dr. Kevin Pehr
|
| Coordinator |
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
- Participant must be ≥18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
- Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
- Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Participant has a life expectancy of at least 3 months.
- Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding
|
| Exclusion Criteria |
- Absolute contraindications: pregnancy, breastfeeding, drug allergy
-
Relative contraindications:
- moderate to severe hypercholesterolemia (total cholesterol >7.8 mmol/L)
- hypertriglyceridemia (TG >2.55 mmol/L)
- significant hepatic dysfunction (AST > 55IU/L, ALT > 94 IU/L)
- suicidal ideation, pseudotumor cerebri
- refractory nausea or vomiting
- GI pathology that would prevent absorption of oral therapy.
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| |
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Groupe d'étude en oncologie du Québec