Clinical trial · Interventional
Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer
Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT
NCT00167908CI-TRIAL-00001976completedPhase 2ClinicalTrials.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)
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethyol (drug) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Salivary function at 6 months and yearly compared to pre-treatment salivary function
Secondary outcomes (1)
- measure
- Local and regional tumor control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed squamous cell cancer of the head and neck * Eligible sites: oral cavity, oropharynx, hypopharynx, larynx. * Patients requiring postoperative IMRT. * KPS \> 70%. * Patient has signed specific protocol consent prior to registration. * Calcium test within normal limits. * No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years. * Labs completed with 30 days of registration (CBC \& platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation. * Liver CT if alk phos, SGOT, or bili elevated. * Bone scan if elevated alk phos Exclusion Criteria: * Metastatic disease. * Patient using Salagen or concurrent chemotherapy. * Previous XRT for head and neck tumors. * Active untreated infection.
References
Publications (0)
Data not yet available
No reference posted for this study.