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Trial · NCT01556932

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

NCT01556932, Not applicable, Completed, Virginia Commonwealth University; results first posted 2015-10-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Randomized Trial of the Effectiveness of Topical "ABH Gel" vs. Placebo in Cancer Patients With Nausea. Trials, record NCT01556932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01556932

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Randomized Trial of the Effectiveness of Topical "ABH Gel" vs. Placebo in Cancer Patients With Nausea
NCT number
NCT01556932
Status
Completed
Phases
Not applicable
Enrollment
22 participants, actual
Lead sponsor
Virginia Commonwealth University
Conditions
Nausea, Vomiting
Interventions
ABH gel, placebo
First posted
2012-03-19
Last updated
2015-10-16
Results first posted
2015-10-16

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.60 minutes after application
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.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYThe Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.60 minutes after application
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.
units on a scaleMEAN

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.ABH Gel1.70Standard Deviation 2.05units on a scale
The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.Placebo0.90Standard Deviation 2.47units on a scale

Participant flow24

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Baseline First TreatmentSTARTEDABH Gel- Placebo13
Baseline First TreatmentSTARTEDPlacebo-ABH Gel9
Baseline First TreatmentRecievedABH Gel- Placebo13
Baseline First TreatmentRecievedPlacebo-ABH Gel9
Baseline First TreatmentCOMPLETEDABH Gel- Placebo13
Baseline First TreatmentCOMPLETEDPlacebo-ABH Gel9
Baseline First TreatmentNOT COMPLETEDABH Gel- Placebo0
Baseline First TreatmentNOT COMPLETEDPlacebo-ABH Gel0
Time Point 60 MinutesSTARTEDABH Gel- Placebo13
Time Point 60 MinutesSTARTEDPlacebo-ABH Gel9

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityArm A and Arm B
Total, other adverse eventsArm A and Arm B022
Total, serious adverse eventsArm A and Arm B022

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01556932

GET https://conductscience.org/api/trials/v1/NCT01556932/flow?page=2