Head and Neck Cancer
Conditions
Brief summary
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.
Interventions
DRUGEthyol (drug)
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary function at 6 months and yearly compared to pre-treatment salivary function | — |
Secondary
| Measure | Time frame |
|---|---|
| Local and regional tumor control | — |
Outcome results
None listed