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

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ClinicalTrials.gov Identifier: NCT00503776
Recruitment Status : Terminated (funding became unavailable)
First Posted : July 19, 2007
Results First Posted : December 8, 2011
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 41
Recruitment Details This study was open to accrual from 01/01/2006 through 03/05/2008.
Pre-assignment Details 43 patients consented, one was ineligible for a total of 42 patients on study.
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description 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 receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Period Title: Overall Study
Started 8 12 12 [1] 10 [1]
Completed 7 12 10 8
Not Completed 1 0 2 2
Reason Not Completed
Withdrawal by Subject             1             0             1             1
Physician Decision             0             0             1             1
[1]
one patient withdrew before receiving protocol therapy
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB Total
Hide Arm/Group Description 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 receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB. Total of all reporting groups
Overall Number of Baseline Participants 8 12 12 10 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 12 participants 12 participants 10 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
12
 100.0%
10
  83.3%
10
 100.0%
40
  95.2%
>=65 years
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
2
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 12 participants 12 participants 10 participants 42 participants
51  (1) 55  (1) 54  (1) 55  (1) 54  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 12 participants 12 participants 10 participants 42 participants
Female
3
  37.5%
1
   8.3%
2
  16.7%
0
   0.0%
6
  14.3%
Male
5
  62.5%
11
  91.7%
10
  83.3%
10
 100.0%
36
  85.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 12 participants 12 participants 10 participants 42 participants
8 12 12 10 42
1.Primary Outcome
Title Number of Patients With Each Degree of Swallowing Dysfunction
Hide Description 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
Time Frame 6 months after concurrent chemotherapy and radiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One patient (Arm 2B) did not undergo the 6-month study
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description:
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 receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Overall Number of Participants Analyzed 8 12 12 9
Measure Type: Number
Unit of Measure: participants
No. of patients with dysphagia grade 0 2 1 2 3
No. of patients with dysphagia grade 1 1 5 4 4
No. of patients with dysphagia grade 2 1 1 2 1
No. of patients with dysphagia grade 3 3 1 1 0
No. of patients with dysphagia grade 4 0 0 0 0
Not Accessible 1 4 3 1
2.Secondary Outcome
Title Stimulated and Unstimulated Salivary Production
Hide Description Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.
Time Frame 6 months after concurrent chemotherapy and radiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2)
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description:
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 receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Overall Number of Participants Analyzed 7 8 9 8
Mean (Standard Deviation)
Unit of Measure: mL per minute
Unstimulated 0.64  (0.37) 1.70  (1.44) 1.38  (1.90) 0.68  (0.32)
Stimulated 0.72  (1.85) 5.04  (3.16) 5.25  (3.39) 0.94  (2.25)
3.Secondary Outcome
Title Number of Patients With Oral Mucositis by Grade
Hide Description Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).
Time Frame 6 months after concurrent chemotherapy and radiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description:
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 receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Overall Number of Participants Analyzed 7 8 9 8
Measure Type: Number
Unit of Measure: participants
No. of patients with grade 0, no mucositis 3 4 6 3
No. of patients with grade 1, mild mucositis 0 4 2 3
No of patients with grade 2, moderate mucositis 1 0 1 2
No of patients with grade 3, severe mucositis 3 0 0 0
No. of patients with grade 4, disabling mucositis 0 0 0 0
No. of patients with grade 5 mucositis, death 0 0 0 0
4.Secondary Outcome
Title Changes in the Amount and Texture of Food Consumed
Hide Description Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.
Time Frame at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding, sufficient data for analysis was not collected.
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description:

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients undergo SNT and low weight resistance training (LWRT).

exercise intervention: Patients undergo low weight resistance training.

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

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.

amifostine trihydrate: Given subcutaneously

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

exercise intervention: Patients undergo low weight resistance training.

amifostine trihydrate: Given subcutaneously

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Changes in the Frequency and Types of Dietary Intakes
Hide Description Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.
Time Frame at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding, sufficient data for analysis was not collected.
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description:

Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients undergo SNT and low weight resistance training (LWRT).

exercise intervention: Patients undergo low weight resistance training.

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

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.

amifostine trihydrate: Given subcutaneously

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.

exercise intervention: Patients undergo low weight resistance training.

amifostine trihydrate: Given subcutaneously

therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm IA Arm IB Arm IIA Arm IIB
Hide Arm/Group Description 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 receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
All-Cause Mortality
Arm IA Arm IB Arm IIA Arm IIB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm IA Arm IB Arm IIA Arm IIB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/12 (0.00%)      2/12 (16.67%)      4/9 (44.44%)    
Ear and labyrinth disorders         
accute hearing loss  0/8 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders         
Diarrhea  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
Constipation  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
mucositis/stomatitis-oral cavity  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 3/9 (33.33%)  3
Nausea  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 2/9 (22.22%)  2
Pain - abdomen NOS  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
pain - oral cavity  0/8 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/9 (11.11%)  1
pain - rectal  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
vomiting  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
General disorders         
pain - larynx  0/8 (0.00%)  0 0/12 (0.00%)  0 2/12 (16.67%)  2 0/9 (0.00%)  0
pain - NOS  0/8 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/9 (11.11%)  1
Fever-in absence of neutropenia  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
Rigor, chills  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/9 (11.11%)  1
edema limb  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
Infections and infestations         
Infection with normal ANC or Grade 1 or 2 neutrophils-blood  0/8 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/9 (11.11%)  1
Investigations         
weight loss  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders         
Muscle weakness - lower extremity  0/8 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/9 (11.11%)  1
rash/desquamation  0/8 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/9 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm IA Arm IB Arm IIA Arm IIB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/8 (87.50%)      12/12 (100.00%)      10/12 (83.33%)      8/9 (88.89%)    
Gastrointestinal disorders         
constipation  7/8 (87.50%)  22 10/12 (83.33%)  23 9/12 (75.00%)  24 6/9 (66.67%)  14
diarrhea  4/8 (50.00%)  8 3/12 (25.00%)  4 3/12 (25.00%)  4 3/9 (33.33%)  4
difficulty chewing  6/8 (75.00%)  17 11/12 (91.67%)  30 9/12 (75.00%)  29 8/9 (88.89%)  23
dysphagia  7/8 (87.50%)  32 12/12 (100.00%)  46 10/12 (83.33%)  42 8/9 (88.89%)  34
mucositis  7/8 (87.50%)  29 12/12 (100.00%)  40 9/12 (75.00%)  33 8/9 (88.89%)  32
nausea  7/8 (87.50%)  21 6/12 (50.00%)  13 8/12 (66.67%)  17 8/9 (88.89%)  15
vomiting  6/8 (75.00%)  13 6/12 (50.00%)  12 8/12 (66.67%)  12 6/9 (66.67%)  8
dry mouth  7/8 (87.50%)  32 12/12 (100.00%)  46 10/12 (83.33%)  40 8/9 (88.89%)  31
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Barbara Murphy, MD
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-343-9444
Responsible Party: Barbara Murphy, MD, 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
First Submitted: July 17, 2007
First Posted: July 19, 2007
Results First Submitted: November 3, 2011
Results First Posted: December 8, 2011
Last Update Posted: June 20, 2017