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

Nausea Clinical Trial

Official title:

A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556932
• Other study ID #: MCC-14141
• Secondary ID: NCI-2012-00220
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: October 15, 2015
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies ABH (lorazepam, diphenhydramine hydrochloride, and haloperidol) gel in patients with nausea. ABH gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting. The general purpose of this research study is to improve the treatment of nausea and vomiting.

Description:

PRIMARY OBJECTIVES:

I. The primary outcome is the change in numeric rating scale in self-reported nausea on a 0-10 scale from baseline to 60 minutes of treatment.

OUTLINE: All individuals who are eligible are randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. The randomization list will be generated by the Study Biostatistician. Neither the patient nor the investigator will have knowledge of the actual content of Drug A or B, so the study will be double-blinded, and placebo controlled.

Drug A: The dose of the drugs in the 1.0 mL dose will be 2 mg of lorazepam, 25 mg of diphenhydramine, and 2 mg of haloperidol in a pluronic lecithin organogel. It will be rubbed on the volar surface of the wrists by the subject, for 2 minutes as done in clinical practice, at time 0. Drug B: equivalent but no ABH.

Subjects will rub 1 mL of the first drug, Drug A gel, between their wrists for 2 minutes.

Subjects will be asked to rate and complete their nausea on the Memorial Symptom Assessment Scale (CMSAS). At time 60 two options can occur. One, if there is no effect after the first drug in one hour, then patients will receive the second drug. If there is no effect in one hour from second drug, patients will stop the study and resume normal treatment for their nausea. Or two, if the first gel reduces nausea by more than 1 point on the 0-10 scale, subjects will wait 4 hours to apply the next gel. At this point, the study procedures will be repeated. After treatment, patients are followed up for up to 8 hours.

Subjects will be asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale at baseline, 60, 120, 180, and 240 minutes.

Subjects will complete the Memorial Symptom Assessment Scale (CMSAS), a reliable and valid instrument for assessing relevant symptoms including lack of energy, lack of appetite, pain, dry mouth, weight loss, feeling drowsy, shortness of breath, constipation, difficulty sleeping, difficulty concentrating, and nausea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking

• No allergies to the drugs

• Able to complete the forms

• If a woman of childbearing age, agree to use contraception; women will be offered a pregnancy test before doing the trial if they request one, as stated in the Informed Consent Form

• Patients must have a self reported nausea score of at least 4 on a numeric rating scale of 0-10 (zero being no nausea and ten being the worst possible nausea); patients are not required to have vomiting

• Patients must have had or have cancer, or have had a consultation with the palliative care team

• They must not have had any changes to their nausea program within the past 12 hours, if on anti-emetics

• Patients must not have received chemotherapy within 5 days, unless it is a stable oral chemotherapy drug such as capecitabine (Xeloda), erlotinib (Tarceva), or similar

Exclusion Criteria:

• History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age)

• Use of any medication that would contraindicate benzodiazepine administration

• Pregnant or nursing

• Children

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• ABH gel
Given topically

Other:
• placebo
Given topically

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of 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.	60 minutes after application	No