Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503776
Status:
TERMINATED
Last Update Posted:
2017-06-20
First Post:
2007-07-17
Brief Title:
ChemoXRT - Amifostine to Assess Outcomes Related to Xerostomia Mucositis Dysphagia
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional Inflammatory and Physical Outcomes Related to Xerostomia Mucositis and Dysphagia
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding became unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Amifostine may decrease the side effects caused by chemotherapy and radiation therapy It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer
PURPOSE This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer
PURPOSE This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Primary
To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine
To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine
To assess the effects of dysphagia xerostomia and mucositis-related inflammation on nutritional physical and functional status
OUTLINE Patients undergo intensity-modulated radiotherapy IMRT and concurrent chemotherapy comprising carboplatin and paclitaxel weekly
Patients are randomized to 1 of 2 treatment arms
Arm I standard of care Patients are further divided into 1A or 1B
Arm IA Standard of care plus standardized nutrition therapy SNT
Arm IB Standard of care plus standardized nutrition therapy plus low weight resistance training LWRT
Arm II amifostine Patients are further divided into 2A or 2B
Arm IIA Amifostine 500mg diluted in 29 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
Arm IIB Amifostine 500mg diluted in 29 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training
In all arms patients undergo swallowing function dietary body composition muscle and physical and functional performance measurements at baseline and at 1 3 and 6 months post-therapy Quality of life salivary production fatigue and symptoms including swallowingeating foods appetite weight lossnutrition pain and speechcommunication are assessed at baseline and at 1 3 and 6 months post-therapy Anthropometric measurements are also performed at the above time points and at mid-therapy
Blood samples and buccal rinses are collected at baseline and at 1 3 and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry
After completion of study treatment patients are followed at 1 3 and 6 months
Primary
To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine
To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine
To assess the effects of dysphagia xerostomia and mucositis-related inflammation on nutritional physical and functional status
OUTLINE Patients undergo intensity-modulated radiotherapy IMRT and concurrent chemotherapy comprising carboplatin and paclitaxel weekly
Patients are randomized to 1 of 2 treatment arms
Arm I standard of care Patients are further divided into 1A or 1B
Arm IA Standard of care plus standardized nutrition therapy SNT
Arm IB Standard of care plus standardized nutrition therapy plus low weight resistance training LWRT
Arm II amifostine Patients are further divided into 2A or 2B
Arm IIA Amifostine 500mg diluted in 29 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
Arm IIB Amifostine 500mg diluted in 29 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training
In all arms patients undergo swallowing function dietary body composition muscle and physical and functional performance measurements at baseline and at 1 3 and 6 months post-therapy Quality of life salivary production fatigue and symptoms including swallowingeating foods appetite weight lossnutrition pain and speechcommunication are assessed at baseline and at 1 3 and 6 months post-therapy Anthropometric measurements are also performed at the above time points and at mid-therapy
Blood samples and buccal rinses are collected at baseline and at 1 3 and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry
After completion of study treatment patients are followed at 1 3 and 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-IRB-051068 | None | None | None |
| VU-VICC-HN-0554 | None | None | None |