Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury

This study has been terminated.
(It was not feasible to recruit required sample size from two clinical sites.)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier:
NCT00031551
First received: March 7, 2002
Last updated: November 24, 2015
Last verified: November 2015
Results First Received: November 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Stomatitis
Interventions: Drug: Etanercept
Drug: Placebo

  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
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
Main Study Participants

Participants were randomized to one of the following two interventions but the study was not unblinded.

  1. Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
  2. Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
Pilot Study Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.

Participant Flow:   Overall Study
    Main Study Participants     Pilot Study  
STARTED     2     25  
COMPLETED     0     25  
NOT COMPLETED     2     0  
Withdrew due to chemotherapy effects                 2                 0  



  Baseline Characteristics
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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
Main Study Participants

Participants were randomized to one of the following two interventions but the study was not unblinded.

  1. Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.
  2. Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.
Pilot Study Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
Total Total of all reporting groups

Baseline Measures
    Main Study Participants     Pilot Study     Total  
Number of Participants  
[units: participants]
  2     25     27  
Age  
[units: years]
Mean (Full Range)
  59   (54 to 64)     46   (32 to 68)     NA   [1]
Gender  
[units: participants]
     
Female     0     13     13  
Male     2     12     14  
Race/Ethnicity, Customized  
[units: participants]
     
White     2     16     18  
Hispanic     0     6     6  
Black     0     2     2  
Asian/Pacific Islander     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     2     25     27  
Education  
[units: participants]
     
Grade School     0     2     2  
High School     0     5     5  
Some College     0     7     7  
College Graduate     1     7     8  
Graduate School     1     4     5  
Cancer Diagnosis  
[units: participants]
     
Breast Cancer     0     7     7  
Non-Hodgkin's Lymphoma     1     8     9  
Hodgkin's Lymphoma     0     4     4  
Multiple Myeloma     1     2     3  
Leukemia     0     4     4  
Cancer stage  
[units: participants]
     
Stage II     0     1     1  
Stage III     1     13     14  
Stage IV     0     5     5  
Unstaged     0     1     1  
First Remission     0     1     1  
Second Remission     0     1     1  
Accelerated Phase     0     1     1  
Unknown     1     2     3  
[1] These numbers reflect two different populations in two different studies and were not analyzed together.



  Outcome Measures
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1.  Primary:   What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis?   [ Time Frame: 2 years ]

2.  Secondary:   What is the Toxicity of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment -Related Stomatitis?   [ Time Frame: 2 years ]

3.  Other Pre-specified:   Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)   [ Time Frame: Day 9 (+/- 24 hours) after conditioning chemotherapy ]

4.  Other Pre-specified:   Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy   [ Time Frame: day 9 (+/- 24 hours) after conditioning chemotherapy ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Suzanne Wingate
Organization: NINR/NIH
phone: 301-827-0982
e-mail: suzanne.wingate@nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT00031551     History of Changes
Other Study ID Numbers: 020133
02-NR-0133 ( Other Identifier: NIH CC )
Study First Received: March 7, 2002
Results First Received: November 24, 2015
Last Updated: November 24, 2015
Health Authority: United States: Federal Government