Study Stopped
funding became unavailable
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
3 other identifiers
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
December 8, 2011
CompletedJune 20, 2017
May 1, 2017
2.6 years
July 17, 2007
November 3, 2011
May 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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
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
Study Arms (4)
Arm IA
ACTIVE COMPARATORPatients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Arm IB
ACTIVE COMPARATORPatients undergo SNT and low weight resistance training (LWRT).
Arm IIA
EXPERIMENTALPatients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
Arm IIB
EXPERIMENTALPatients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Interventions
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Eligibility Criteria
You may qualify if:
- Age greater than 21
- Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity or salivary glands
- No prior history of active cancer within three years other than non-melanoma skin cancer, early stage prostate or early stage cervical cancer
- controlled co-morbid disease
- ECOG PS of 0-3
- Plan for definitive or post-operative CCR within 4 weeks
- Written informed consent
- Working telephone
- May have received prior induction chemotherapy
- Agree to use only study supplied liquid nutrition supplements or dietary supplements, for per os or feeding tube intake
You may not qualify if:
- Diagnosed HIV or AIDS
- History of ETOH or drug abuse within 3 months
- Pregnant or lactating
- On steroid medication or prescribed NSAIDs
- Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)
- On orexigenic (appetite stimulant) medication.
- Uncontrolled comorbid disease defined as: a) severe cardiac disease Class III or greater; b) blood pressure \> 160/95; c) uncontrolled pain
- Does not have working telephone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barbara Murphy, MD
- Organization
- Vanderbilt-Ingram Cancer Center
Study Officials
- STUDY CHAIR
Barbara A. Murphy, MD
Vanderbilt-Ingram Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 19, 2007
Study Start
January 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
June 20, 2017
Results First Posted
December 8, 2011
Record last verified: 2017-05