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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT05143268
Eligibility Criteria:
Inclusion Criteria:
* histologically-confirmed diagnosis of squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx and larynx or histologically-confirmed diagnosis of undifferentiated carcinoma of the nasopharynx
* by judgement of the local investigator, indication for a DNST with curative intent, consisting of one of the 3 following options:
* radiotherapy alone
* cisplatin-based concomitant chemo-radiotherapy
* cetuximab-based concomitant bio-radiotherapy
* clinical stage of disease: II, III, IVA, IVB (according to TNM/AJCC 8th edition) for primary tumors of the larynx, hypopharynx and oropharynx (p16/HPV negative), provided that for stage II disease (cT2N0) the local investigator will prescribe an elective irradiation of regional lymph nodes
* clinical stage of disease: I, II, III (according to TNM/AJCC 8th edition) for primary tumors of the oropharynx (p16/HPV positive), provided that for stage I disease (cT1N0) the local investigator will prescribe an elective irradiation of regional lymph nodes
Exclusion Criteria:
* histologically-confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with HNSCC of unknown primary or non-squamous histologies
* metastatic disease
* gross total excision of both primary and nodal disease before index treatment
* surgical manipulation including therapeutic tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
* prior radiotherapy to the head and neck region
* induction chemotherapy prior to radiotherapy
* prior use of acupuncture for SCCHN or for different indications
* prior allergic reaction or history of hypersensitivity to inox austenitic steel (Cr18Ni9)
* active or prior documented neurologic or rheumatologic disorder with a potential impact on the swallowing function (i.e: multiple sclerosis, amyotrophic lateral sclerosis, scleroderma)
* active process of severe skin infection in the neck contraindicating the execution of acupuncture in the opinion of the investigator
* severe baseline dysphagia documented by a MDADI scale (MD Anderson Dysphagia Inventory) composite score below 60
* any condition that, in the opinion of the investigator, would not require to encompass at least ipsilateral neck lymph nodes in the irradiation field
* any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05143268
Study Brief:
Protocol Section:
NCT05143268