Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
|ClinicalTrials.gov Identifier: NCT00409331|
Recruitment Status : Terminated (Study terminated by Principal Investigator; no patients completed study.)
First Posted : December 8, 2006
Results First Posted : January 18, 2010
Last Update Posted : August 7, 2012
To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.
To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:
- When the mean dose is < 24-26 Gy (shift recovery time to left)
- When the mean dose is > 24-26 Gy (DVH shift)
To observe mucositis in the following lower dose RT areas:
- Upper lip
- Lower lip
- Right cheek
- Left cheek
- Right ventral and lateral tongue
- Left ventral and lateral tongue
- Floor of the mouth
- Soft palate
- Hard palate.
- To observe the incidence and patterns of occipital scalp epilation;
- To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
- To further evaluate the safety profile of amifostine in this patient population.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Amifostine Procedure: Intensity- Modulated Radiation Therapy||Phase 2|
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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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2006|
|Primary Completion Date :||January 2009|
|Study Completion Date :||January 2009|
Experimental: IMRT + Amifostine
Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
Other Name: EthyolProcedure: Intensity- Modulated Radiation Therapy
2.0 to 2.2 Gy delivered in 30 fractions
Other Name: IMRT
- 12-month Clinically Relevant Salivary Flow (CRSF) [ Time Frame: 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409331
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mark Chambers, MD||M.D. Anderson Cancer Center|