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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT01596933
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, (naso)pharynx and larynx. Cancer of the parotid gland, or nasal cavity and paranasal sinuses are excluded, as well as cT1 N0 M0 tumours of the glottis.
* Primary cancer or relapse, eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent
* TNM stage I to IVB, without distant metastases
* Patients should be older than 18 at the time of enrolment
* Patients should be able to adequately communicate in Dutch or French
Exclusion Criteria:
* Patients younger than 18 years at the time of recruitment
* Pregnant or lactating women
* Patients presenting with another non-cured cancer (PSA or CEA not within normal range as determined by the treating physician)
* Patients that already underwent a radio(chemo)therapy treatment within the last 6 months
* Patients taking oral anticoagulants or LMWH at therapeutic doses
* Patients taking anti-epileptics
* Patients with an indication of heart failure NYHA 3 or 4, or presence of an implantable cardioverter-defibrillator
* Patients with a pacemaker will be excluded from BIA-analysis
* Patients presenting with active intestinal co-morbidity, precluding adequate dietary intake or interfering with the absorption of the nutritional supplements (eg Crohn's disease)
* Patients with a known eating disorder (eg anorexia nervosa, bulimia nervosa)
* Patients with uncontrollable diabetes
* HIV-positive patients
* Patients with (severe) dementia (DSM-IV criteria)
* Patients actively taking fish oil, echium oil or omega-3 FA supplements in the last 4 weeks before enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01596933
Study Brief:
Protocol Section:
NCT01596933