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Trial record 11 of 64 for:    dry mouth | NIH

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

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

Baseline Measures
   Arm IA   Arm IB   Arm IIA   Arm IIB   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   12   12   10   42 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 51  (1)   55  (1)   54  (1)   55  (1)   54  (1) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   8   12   12   10   42 


  Outcome Measures

1.  Primary:   Number of Patients With Each Degree of Swallowing Dysfunction   [ Time Frame: 6 months after concurrent chemotherapy and radiation ]

Measure Type Primary
Measure Title Number of Patients With Each Degree of Swallowing Dysfunction
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One patient (Arm 2B) did not undergo the 6-month 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.

Measured Values
   Arm IA   Arm IB   Arm IIA   Arm IIB 
Participants Analyzed   8   12   12   9 
Number of Patients With Each Degree of Swallowing Dysfunction 
[Units: 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 

No statistical analysis provided for Number of Patients With Each Degree of Swallowing Dysfunction



2.  Secondary:   Stimulated and Unstimulated Salivary Production   [ Time Frame: 6 months after concurrent chemotherapy and radiation ]

Measure Type Secondary
Measure Title Stimulated and Unstimulated Salivary Production
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

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.

Measured Values
   Arm IA   Arm IB   Arm IIA   Arm IIB 
Participants Analyzed   7   8   9   8 
Stimulated and Unstimulated Salivary Production 
[Units: mL per minute]
Mean (Standard Deviation)
       
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) 

No statistical analysis provided for Stimulated and Unstimulated Salivary Production



3.  Secondary:   Number of Patients With Oral Mucositis by Grade   [ Time Frame: 6 months after concurrent chemotherapy and radiation ]

Measure Type Secondary
Measure Title Number of Patients With Oral Mucositis by Grade
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

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.

Measured Values
   Arm IA   Arm IB   Arm IIA   Arm IIB 
Participants Analyzed   7   8   9   8 
Number of Patients With Oral Mucositis by Grade 
[Units: 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 

No statistical analysis provided for Number of Patients With Oral Mucositis by Grade



4.  Secondary:   Changes in the Amount and Texture of Food Consumed   [ Time Frame: at baseline, at 1 month, 3 months and 6 months post-chemoradiation ]

Measure Type Secondary
Measure Title Changes in the Amount and Texture of Food Consumed
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Due to loss of funding, sufficient data for analysis was not collected.

Reporting Groups
  Description
Arm IA

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.

Arm IB

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.

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.

amifostine trihydrate: Given subcutaneously

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

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.

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.


Measured Values
   Arm IA   Arm IB   Arm IIA   Arm IIB 
Participants Analyzed   0   0   0   0 
Changes in the Amount and Texture of Food Consumed         

No statistical analysis provided for Changes in the Amount and Texture of Food Consumed



5.  Secondary:   Changes in the Frequency and Types of Dietary Intakes   [ Time Frame: at baseline, at 1 month, 3 months and 6 months post-chemoradiation ]

Measure Type Secondary
Measure Title Changes in the Frequency and Types of Dietary Intakes
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Due to loss of funding, sufficient data for analysis was not collected.

Reporting Groups
  Description
Arm IA

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.

Arm IB

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.

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.

amifostine trihydrate: Given subcutaneously

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

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.

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.


Measured Values
   Arm IA   Arm IB   Arm IIA   Arm IIB 
Participants Analyzed   0   0   0   0 
Changes in the Frequency and Types of Dietary Intakes         

No statistical analysis provided for Changes in the Frequency and Types of Dietary Intakes




  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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
e-mail: barbara.murphy@vanderbilt.edu



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