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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT03034603
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
2. Finished radiotherapy or/and chemotherapy for at least one month
3. Has at least one measurable target lesion
4. Baseline KPS ≥ 40% or ECOG 0-3
5. Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
6. Able to take the intervention (through mouth or NG tube) without aspiration
7. Able to communicate and consent to the study
Exclusion Criteria:
1. Cannot come back for the follow-up visits
2. Receive or had received N-acetylcysteine during the intervention
3. Has systemic diseases that might interfere with the results
4. Chronic kidney disease that requires dialysis
5. Increased risk of aspiration pneumonia
6. Pregnancy or lactation
7. Untreated infectious diseases
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03034603
Study Brief:
Protocol Section:
NCT03034603