NCT00503776|TerminatedPhase 2ResultsDMC
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Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
Sponsor study identifier
Secondary identifiers
interventional
41
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 17, 2007
Actual (reported)July 19, 2007
Actual (reported)August 2008
Actual (reported)August 2008
Actual (reported)December 8, 2011
Actual (reported)Number of Patients With Each Degree of Swallowing Dysfunction
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
6 months after concurrent chemotherapy and radiation
Stimulated and Unstimulated Salivary Production
6 months after concurrent chemotherapy and radiation
Number of Patients With Oral Mucositis by Grade
6 months after concurrent chemotherapy and radiation
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Patients undergo SNT and low weight resistance training (LWRT).
Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
Patients undergo low weight resistance training.
Given subcutaneously
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Barbara A. Murphy, MD
Vanderbilt-Ingram Cancer Center
41 participants (actual enrollment reported by the registry).
First Submitted
July 17, 2007
First Posted
July 19, 2007
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Changes in the Amount and Texture of Food Consumed
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Changes in the Frequency and Types of Dietary Intakes
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
June 20, 2017
Results First Posted
December 8, 2011
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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