Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168116

Enrollment

Registered

2005-09-15

Start date

2000-07-31

Completion date

2009-06-30

Last updated

2016-02-24

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

Conditions

Head and Neck Cancer

Keywords

nasopharynx, xerostomia, prevention

Brief summary

The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.

Interventions

PROCEDUREradiation treatment and surgery

PROCEDUREradiation alone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a histological diagnosis of squamous cell carcinoma * Patients with unilateral or no neck involvement of the nasopharynx * The submandibular transfer will be done on the uninvolved side of the neck. * Karnofsky score greater than or equal to 70 * Expected survival greater than one year * A signed informed consent

Exclusion criteria

* Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.

Design outcomes

Primary

Measure	Time frame
Quality of life	—

Secondary

Measure	Time frame
Incidence of percutaneous endoscopic gastronomy (PEG)	—
Incidence of oral candidiasis	—
Overall survival	—
Treatment interruptions	—
Pattern of recurrence	—
Complications	—
Disease free survival	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026