Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia

This study has been terminated.

( funding became unavailable )

Study NCT00503776 Information provided by Vanderbilt-Ingram Cancer Center

First Received on July 17, 2007. Last Updated on November 3, 2011 History of Changes

Results First Received: November 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Conditions:	Dysphagia Head and Neck Cancer Mucositis Xerostomia
Interventions:	Behavioral: exercise intervention Drug: amifostine trihydrate Procedure: therapeutic dietary intervention

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was open to accrual from 01/01/2006 through 03/05/2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
43 patients consented, one was ineligible for a total of 42 patients on study.

Reporting Groups

	Description
Arm IA	Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Arm IB	Patients undergo SNT and low weight resistance training (LWRT).
Arm IIA	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.
Arm IIB	Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

Participant Flow: Overall Study

	Arm IA	Arm IB	Arm IIA	Arm IIB
STARTED	8	12	12 ^[1]	10 ^[1]
COMPLETED	7	12	10	8
NOT COMPLETED	1	0	2	2
Withdrawal by Subject	1	0	1	1
Physician Decision	0	0	1	1

[1]	one patient withdrew before receiving protocol therapy

Baseline Characteristics

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Reporting Groups

	Description
Arm IA	Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Arm IB	Patients undergo SNT and low weight resistance training (LWRT).
Arm IIA	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.
Arm IIB	Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

Baseline Measures

	Arm IA	Arm IB	Arm IIA	Arm IIB	Total
Number of Participants [units: participants]	8	12	12	10	42
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	8	12	10	10	40
>=65 years	0	0	2	0	2
Age [units: years] Mean ± Standard Deviation	51 ± 1	55 ± 1	54 ± 1	55 ± 1	54 ± 1
Gender [units: participants]
Female	3	1	2	0	6
Male	5	11	10	10	36
Region of Enrollment [units: participants]
United States	8	12	12	10	42

Outcome Measures

1. Primary:

Number of Patients With Each Degree of Swallowing Dysfunction as Measured by the Modified Barium Swallow Score [ Time Frame: 6 months after concurrent chemothearpy and radiation ]

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2. Secondary:

Stimulated and Unstimulated Salivary Production [ Time Frame: 6 months after concurrent chemothearpy and radiation ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Changes in the Amounts and Textures of Food Consumed as Measured by 24-hour Dietary Recalls [ Time Frame: 6 months after concurrent chemothearpy and radiation ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Mucositis as Measured by CTC 3.0 [ Time Frame: 6 months after concurrent chemothearpy and radiation ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

5. Secondary:

Biochemical and Inflammatory Markers Including C-reactive Protein and Cytokines and a Marker of Whole Body Oxidative Stress [ Time Frame: 6 months after concurrent chemothearpy and radiation ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

Changes in the Frequency and Types of Dietary Intakes as Measured by 24-hour Dietary Recalls [ Time Frame: 6 months after concurrent chemothearpy and radiation ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Barbara Murphy, MD
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-343-9444
e-mail: barbara.murphy@vanderbilt.edu

No publications provided

Responsible Party:	Barbara Murphy, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00503776 History of Changes
Other Study ID Numbers:	VICC HN 0554, VU-VICC-HN-0554, VU-VICC-IRB-051068
Study First Received:	July 17, 2007
Results First Received:	November 3, 2011
Last Updated:	November 3, 2011
Health Authority:	United States: Federal Government