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Clinical Study on Normal Tissue Protection (Dosimetric Analysis) and Auxiliary Posture Fixation of a New Multifunctional Oral Stent in Head and Neck Cancer Patients Undergoing Radiotherapy

Clinical Study on Normal Tissue Protection (Dosimetric Analysis) and Auxiliary Posture Fixation of a New Multifunctional Oral Stent in Head and Neck Cancer Patients Undergoing Radiotherapy - Clinical Study on Normal Tissue Protection and Posture Fixation Using a Novel Multifunctional Oral Stent in Head and Neck Cancer Radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119541
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Interventions

Sequence Group 1:First receive "oral stent placement + intensity-modulated radiotherapy (IMRT)" (Phase A, 17 fractions),then receive "no oral stent placement + IMRT" (Phase B, 16 fractions).
Sequence Group 2:First receive "no oral stent placement + IMRT" (Phase B, 17 fractions), followed by "oral stent placement + intensity-modulated radiotherapy (IMRT)" (Phase A, 16 fractions).

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients with histopathologically confirmed head and neck cancer scheduled to receive radical or adjuvant radiotherapy, including nasopharyngeal carcinoma, nasopharyngeal carcinoma with invasion of the nasal cavity and hard palate, nasal cavity cancer, paranasal sinus cancer, soft and hard palate cancer, tongue cancer, gingival cancer, floor of mouth cancer, etc; 2.Aged between 18 and 85 years, regardless of gender; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 4.No oral diseases, obvious trismus, or severe maxillofacial deformities; 5.Patients have signed the informed consent form and relevant treatment consent forms.

Exclusion criteria

Exclusion criteria: 1.Patients who are unable to understand and comply with the requirements of the study protocol; 2.Patients with oral diseases, obvious trismus, or severe maxillofacial deformities; 3.Patients with tooth loss affecting the stability and repeatability of the stent; 4.Patients with allergy to silicone rubber materials.

Design outcomes

Primary

MeasureTime frame
Dosimetric parameters of normal tissues (tongue, parotid gland): Dmean, Dmin, Dmax;—

Secondary

MeasureTime frame
Setup errors (mm) in the three-dimensional directions (X, Y, Z axes) measured by CBCT before each fraction during radiotherapy in patients with nasopharyngeal carcinoma.;—

Countries

China

Contacts

Public ContactLi Mengyan

The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)

limengyan@sysush.com+86 136 6011 7146

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026