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Trial record 11 of 62 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 ]

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

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

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 ]

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 ]


  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