Clinical trial · Interventional
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
NCT00168181CI-TRIAL-00004695completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salagen | Drug | — | UNRESOLVED |
| Submandibular gland Transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (1)
- measure
- To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.