Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409331
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2006-12-07
Brief Title:
Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by Principal Investigator no patients completed study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
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
Secondary Objectives
1 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
2 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
3 To observe the incidence and patterns of occipital scalp epilation
4 To observe the incidence of dysphagia using the List Performance Status Scale LPSS and
5 To further evaluate the safety profile of amifostine in this patient population
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
Secondary Objectives
1 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
2 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
3 To observe the incidence and patterns of occipital scalp epilation
4 To observe the incidence of dysphagia using the List Performance Status Scale LPSS and
5 To further evaluate the safety profile of amifostine in this patient population
Detailed Description:
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 waterYou 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 MD 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 MD 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
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 waterYou 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 MD 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 MD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None