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:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT02906800
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes, with primary unresectable, advanced (stage III-IV) HNSCC to be treated by cisplatin-based chemotherapy.
* Life expectancy \> 12 months.
* Age \> 18 and \< 70
* WHO PS : 0-2
* Signed informed consent
* creatinine clearance : MDRD \> 60ml/min/1,73m2
* Affiliation to the French Social Security Health Care plan
Exclusion Criteria:
* Difficulties planned for the 6 month follow up during the study period
* Swallowing disorder preventing digoxin treatment
* Severe aortic stenosis or idiopathic hypertrophic subaortic stenosis at the pretreatment echocardiography.
* Hypertrophic or dilated or restrictive cardiomyopathy at the pretreatment echocardiography
* Severe cardiac condition contraindicating the use of digoxin (Constrictive pericarditis, acute cor pulmonale, myocarditis…)
* Acute Myocardial infarction within the past 3 months
* Severe ventricular arrhythmias on ECG at rest including frequent ventricular extrasystoles, ventricular tachycardia/fibrillation
* Second and third degree atrio-ventricular block or sick sinus syndrome on resting ECG without pacemaker
* Wolf Parkinson White syndrome on ECG at rest
* Renal insufficiency (estimated glomerular filtration rate by the MDRD formula \< 60 ml/min/1.73m2)
* Liver insufficiency (Child-Pugh grades B and C)
* Severe uncorrected electrolyte disturbances (hypercalcemia, hypokaliemia, hypomagnesemia…)
* Known hypersensitivity reaction to digoxin
* Compelling indication for continuous use of digoxin
* Use of drugs contraindicated with oral digoxin (Midodrine, calcium salt, millepertuis, sultopride, phenytoin, yellow fever vaccine, live attenuated vaccine)
* Absence of effective contraception methods for men and women during the study and 6 months after the end of the study
* Pregnancy and breastfeeding at inclusion, during the study and 6 months after the end of the study
* HPV positive tumors (These tumors are associated with very good response to chemotherapy alone)
* History of another cancer which treatment is ongoing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
69 Years
Study:
NCT02906800
Study Brief:
Protocol Section:
NCT02906800