Randomized Trial of the Effectiveness of Topical "ABH Gel" vs. Placebo in Cancer Patients With Nausea

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01556932
First received: March 13, 2012
Last updated: October 15, 2015
Last verified: October 2015
Results First Received: March 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Nausea
Vomiting
Interventions: Drug: ABH gel
Other: 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
Participants recruited from Massey Cancer Center, in Richmond City, Virginia USA between March 2012 until May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 participants were consented to the research study. Two of them no longer were nauseous and never started treatment. One subject expired on the study. 22 subjects enrolled but only 20 evaluable subjects' data was completed for analysis.

Reporting Groups
  Description
ABH Gel- Placebo All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with ABH gel first and then went to Placebo.The randomization list will be generated by the Study Biostatistician.
Placebo-ABH Gel All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with Placebo first and then went to ABH gel. The randomization list will be generated by the Study Biostatistician.

Participant Flow for 3 periods

Period 1:   Baseline First Treatment
    ABH Gel- Placebo     Placebo-ABH Gel  
STARTED     13     9  
Recieved     13     9  
COMPLETED     13     9  
NOT COMPLETED     0     0  

Period 2:   Time Point 60 Minutes
    ABH Gel- Placebo     Placebo-ABH Gel  
STARTED     13 [1]   9 [1]
Recieved     12     8  
COMPLETED     12     8  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  
[1] 1 subject withdrew and never started second treatment.

Period 3:   Second Treament
    ABH Gel- Placebo     Placebo-ABH Gel  
STARTED     12     8  
Recieved     12     8  
COMPLETED     12     8  
NOT COMPLETED     0     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.
Patients who were eligible were randomly assigned to two sequences: one group used ABH gel first and then the placebo; and the other group used the placebo first and then ABH gel. We assumed there was no carry-over effect from the first treatment to the second. In total, 22 patients were enrolled but 20 subjects completed the study.

Reporting Groups
  Description
All Participants

All participants go through Placebo-ABH or ABH-placebo depending on the sequence they were randomized to. Patients are randomized into Placebo-ABH or ABH-Placebo sequence.

Sequence 1:Patients apply Drug A gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug B. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug A. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.

Sequence 2:Patients will apply Drug B gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug A. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug B. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.


Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  22  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     1  
Age  
[units: years]
Mean (Standard Deviation)
  48.1600  (14.1500294)  
Gender  
[units: participants]
 
Female     16  
Male     6  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     20  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     16  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures

1.  Primary:   The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.   [ Time Frame: 60 minutes after application ]


  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: Devon S. Flecher, MD
Organization: Virginia Commonwealth University/ Hospice & Pallative Medicine
phone: 804-828-9723
e-mail: dsfletcher@mcvh-vcu.edu


No publications provided


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01556932     History of Changes
Other Study ID Numbers: MCC-14141
NCI-2012-00220 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: March 13, 2012
Results First Received: March 3, 2015
Last Updated: October 15, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government