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Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

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ClinicalTrials.gov Identifier: NCT01156142
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : May 8, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Head and Neck Cancer
Mucositis
Oral Complications of Radiation Therapy
Pain
Interventions: Drug: doxepin hydrochloride
Other: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Doxepin-Placebo) Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
Arm II (Placebo-Doxepin) Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.

Participant Flow:   Overall Study
    Arm I (Doxepin-Placebo)   Arm II (Placebo-Doxepin)
STARTED   77   78 
COMPLETED   69   71 
NOT COMPLETED   8   7 
Withdrawal by Subject                8                6 
Ineligible                0                1 



  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 I (Doxepin-Placebo) Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
Arm II (Placebo-Doxepin) Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
Total Total of all reporting groups

Baseline Measures
   Arm I (Doxepin-Placebo)   Arm II (Placebo-Doxepin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   71   140 
Age 
[Units: Years]
Mean (Full Range)
 62 
 (39.0 to 93.0) 
 60 
 (37.0 to 86.0) 
 61 
 (37.0 to 93.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  18.8%      15  21.1%      28  20.0% 
Male      56  81.2%      56  78.9%      112  80.0% 
Region of Enrollment 
[Units: Participants]
     
United States   69   71   140 


  Outcome Measures

1.  Primary:   Total Pain Reduction (Mouth and Throat)   [ Time Frame: Baseline and Day 1 ]

2.  Secondary:   Total Taste of the Oral Rinse   [ Time Frame: Up to 9 days ]

3.  Secondary:   Total Stinging or Burning From the Oral Rinse   [ Time Frame: Up to 9 days ]

4.  Secondary:   Total Drowsiness Increase   [ Time Frame: Up to 9 days ]

5.  Secondary:   Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash   [ Time Frame: Up to 9 days ]

6.  Secondary:   Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride   [ Time Frame: Up to 9 days ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert C. Miller, M.D.
Organization: Mayo Clinic
phone: 507/266-6247
e-mail: Miller.Robert@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01156142     History of Changes
Other Study ID Numbers: NCCTG-N09C6
NCI-2011-02049 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000675520 ( Registry Identifier: PDQ (Physician Data Query) )
U10CA037404 ( U.S. NIH Grant/Contract )
First Submitted: July 1, 2010
First Posted: July 2, 2010
Results First Submitted: December 12, 2016
Results First Posted: May 8, 2017
Last Update Posted: August 9, 2017