Trial Outcomes & Findings for Randomized Trial of the Effectiveness of Topical "ABH Gel" vs. Placebo in Cancer Patients With Nausea (NCT NCT01556932)
NCT ID: NCT01556932
Last Updated: 2015-10-16
Results Overview
The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a "prn" (as needed) gel in actual practice, when relief is needed in short order.
COMPLETED
NA
22 participants
60 minutes after application
2015-10-16
Participant Flow
Participants recruited from Massey Cancer Center, in Richmond City, Virginia USA between March 2012 until May 2013.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Baseline First Treatment
STARTED
|
13
|
9
|
|
Baseline First Treatment
Recieved
|
13
|
9
|
|
Baseline First Treatment
COMPLETED
|
13
|
9
|
|
Baseline First Treatment
NOT COMPLETED
|
0
|
0
|
|
Time Point 60 Minutes
STARTED
|
13
|
9
|
|
Time Point 60 Minutes
Recieved
|
12
|
8
|
|
Time Point 60 Minutes
COMPLETED
|
12
|
8
|
|
Time Point 60 Minutes
NOT COMPLETED
|
1
|
1
|
|
Second Treament
STARTED
|
12
|
8
|
|
Second Treament
Recieved
|
12
|
8
|
|
Second Treament
COMPLETED
|
12
|
8
|
|
Second Treament
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Time Point 60 Minutes
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Randomized Trial of the Effectiveness of Topical "ABH Gel" vs. Placebo in Cancer Patients With Nausea
Baseline characteristics by cohort
| Measure |
All Participants
n=22 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
48.1600 years
STANDARD_DEVIATION 14.1500294 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutes after applicationPopulation: 25 participants were consented, two subjects declined treatment, one expired subject. Two subjects refused to continue after first treatment and did not complete the second treatment. Only 20 patients were analyzed because of missing data not done by those two subjects on the second treatment.
The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a "prn" (as needed) gel in actual practice, when relief is needed in short order.
Outcome measures
| Measure |
ABH Gel
n=20 Participants
ABH Gel applied topically for 2 minutes.
|
Placebo
n=20 Participants
Placebo applied topically for 2 minutes.
|
|---|---|---|
|
The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.
|
1.70 units on a scale
Standard Deviation 2.05
|
0.90 units on a scale
Standard Deviation 2.47
|
Adverse Events
Arm A and Arm B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Devon S. Flecher, MD
Virginia Commonwealth University/ Hospice & Pallative Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place