| Titre |
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 |
| Type(s) de cancer |
Contrôle des symptômes |
| Phase |
Phase IV |
| Type étude |
Clinique |
| Médicament |
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
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Kevin Pehr
|
| Coordonnateur(trice) |
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- 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.
|
Groupe d'étude en oncologie du Québec