Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients

A Phase III Randomized Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168181

Enrollment

220

Registered

2005-09-15

Start date

2002-04-30

Completion date

2008-04-30

Last updated

2011-04-18

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

Conditions

Cancer, Head and Neck Cancer

Keywords

salagen, gland transfer, randomized, xerostomia

Brief summary

This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.

Interventions

PROCEDURESubmandibular gland Transfer

DRUGSalagen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Previously untreated and confirmed histological diagnosis of squamous cell/adenoid cystic carcinoma of the oropharynx, hypopharynx, larynx, and patients with unknown primary tumor with metastases to the neck nodes and squamous cell carcinoma of the skin of head and neck region with ipsilateral neck nodes (more than one node) metastases. 2. Radiation volume to encompass \> or equal to 80% of major salivary glands (parotids and the non-transferred submandibular salivary gland) and have \> or equal to 50 Gys delivered to that volume via external beam. 3. Karnofsky performance score \> or equal to 70 4. Minimum age 18 years 5. The patient must sign a study-specific informed consent prior to study entry 6. Expected survival \> or equal to one year

Exclusion criteria

1. Carcinoma of nasopharynx, oral cavity, N3 disease, bilateral neck node involvement, pre-epiglottic space involvement, involvement of level 1 nodes on either side of the neck, and patients with post-operative recurrent disease. 2. Salivary gland malignancy 3. Salivary gland disease 4. Use of anti-cholinergic drugs and tricyclic drugs 5. Delay in XRT of more than 8 weeks following the curative surgery 6. Pregnant or lactating females are not eligible. Patients of childbearing potential should agree to use an effective method of contraception 7. Prior head and neck irradiation 8. Recurrent disease 9. Allergy to pilocarpine 10. Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of prevention of XRT induced xerostomia using two different approaches: oral Pilocarpine versus submandibular salivary gland transfer protocol; To compare the rate and severity of XRT induced xerostomia using these two strategies	—

Secondary

Measure	Time frame
To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT	—

Countries

Canada

Outcome results

None listed

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