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

NCT ID: NCT01556932

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-05-31

Brief 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.

Detailed 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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo then ABH

All subjects randomized to two sequences of treatments: either placebo-ABH or ABH-placebo. All participants will receive both drug A and drug B.

After applying gel, Drug A or B, on wrists for 2 minutes, time 0. From baseline to 60 minutes of treatment two options will occur. At 60 minutes, if patients have at least 1 point reduction in their nausea score, they must wait 4 hours before switching to opposite drug. After administration of drug, the study procedures will be repeated. Or, at 60 minutes, if no change or increase in nausea score has been recorded, alternative treatment will be given. If the second treatment is ineffective at one hour (total time 2 hours) then alternative usual medications will be given. After completion of study treatment, patients are followed up for up to 8 hours.

Group Type: EXPERIMENTAL

ABH gel

Intervention Type: DRUG

Given topically

placebo

Intervention Type: OTHER

Given topically

ABH then placebo

All subjects randomized to two sequences of treatments: either placebo-ABH or ABH-placebo. All participants will receive both drug A and drug B.

After applying gel, Drug A or B, on wrists for 2 minutes, time 0. From baseline to 60 minutes of treatment two options will occur. At 60 minutes, if patients have at least 1 point reduction in their nausea score, they must wait 4 hours before switching to opposite drug. After administration of drug, the study procedures will be repeated. Or, at 60 minutes, if no change or increase in nausea score has been recorded, alternative treatment will be given. If the second treatment is ineffective at one hour (total time 2 hours) then alternative usual medications will be given. After completion of study treatment, patients are followed up for up to 8 hours.

Group Type: EXPERIMENTAL

ABH gel

Intervention Type: DRUG

Given topically

placebo

Intervention Type: OTHER

Given topically

Interventions

ABH gel

Given topically

Intervention Type: DRUG

placebo

Given topically

Intervention Type: OTHER

Other Intervention Names

Ativan; lorazepam; diphenhydramine hydrochloride; Benadryl; Bendylate; Eldadryl; SK-Diphenhydramine; haloperidol; Haldol; McN-JR-1625; R-1625; PLCB

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Devon Fletcher

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

NCI-2012-00220

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-14141

Identifier Type: -

Identifier Source: org_study_id