A Phase II Study To Assess The Efficacy of Amifostine for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment With Intensity- Modulated Radiation Therapy (IMRT) for Parotid Salivary Sparing
Amifostine is designed to protect the cells in normal tissues against the toxicities of
chemotherapy and radiation therapy.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study.
Blood (about 2 tablespoons) will be drawn for routine blood tests. Your complete medical
history will be recorded. You will have a physical exam, including measurement of your
vital signs (blood pressure, heart rate, temperature, and breathing rate), weight, and
height. You will have a dental exam. You will complete a questionnaire that asks questions
about dry mouth. In addition, you will be asked questions about your diet and eating
habits. This should take no longer than 10 minutes. Also, saliva will be collected by a
simple, in-office oral test that measures saliva flow rate over a 5 minute period. Women who
are able to have children must have a negative blood (about 1-2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive IMRT Monday
-Friday over a 6-7 week period. In addition, 2-3 hours before IMRT, you will also take
pre-medications by mouth to prevent potential nausea and skin reactions (anti-nausea &
antihistamine), including drinking water.You will receive daily IMRT therapy, excluding
weekends and holidays. The radiation dose is designed to conform to the 3-dimensional shape
of the tumor by controlling the intensity of the radiation beam to focus a higher radiation
dose on the tumor (and not the surrounding normal tissue). Thirty (30) to 60 minutes before
every IMRT treatment, you will receive study drug in two injections beneath the skin. IMRT
will take about 30 minutes to complete.
Every day that you are receiving IMRT (Monday-Friday), you will be asked about any drugs you
are taking and any side effects you are experiencing. Your vital signs will be recorded.
Every week (Weeks 2-7), you will have a complete oral and physical exam. You will complete
the questionnaire that asks questions about dry mouth. You will be asked questions about
your ability to perform daily activities (performance status evaluation). Your weight will
also be measured. You will be asked to complete the symptom survey (the M.D. Anderson
Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms
interfere in your daily activities.
On the last day you receive IMRT or amifostine (whichever is last), you will have a complete
oral exam and you will complete the questionnaire about dry mouth.
Six (6) weeks after the end of therapy, you will have an end-of-therapy visit. At this
visit, you will have a complete physical and oral exam with a saliva collection. You will
complete the questionnaire about dry mouth. Your weight will be measured, and you will have
a performance status evaluation. Blood (about (2) tablespoons) will be drawn for routine
blood tests. You will be asked about any drugs you are taking and any side effects you are
experiencing. In addition, you will be asked questions about your diet and eating habits.
You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that
will ask you to rate your symptoms and how much the symptoms interfere in your daily
activities every week for 2 months after the end of radiation therapy. After this point,
you will be asked to complete the symptom survey every month for 1 year.
You will have follow-up visits 4, 7, 10, and 12 months after the end of therapy. At these
visits, you will have a complete oral exam and saliva collection. You will complete the dry
mouth questionnaire. Your weight will be measured, and you will have a performance status
evaluation and you will be asked questions about your diet and eating habits.
THIS IS AN INVESTIGATIONAL STUDY. Amifostine is FDA approved and commercially available.
Amifostine is FDA approved to be given through a needle in your vein but not FDA approved to
be given through a needle under the skin.
Up to 20 patients will take part in this study. All patients will be enrolled at M. D.
Anderson.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
12-month Clinically Relevant Salivary Flow (CRSF)
Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.
12 months
No
Mark Chambers, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
2006-0234
NCT00409331
December 2006
January 2009
Name | Location |
---|---|
U.T. M.D. Anderson Cancer Center | Houston, Texas 77030 |