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
  Purpose
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.

Condition Intervention
Nausea
Vomiting
Drug: ABH gel
Other: placebo

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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment. [ Time Frame: 60 minutes after application ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: ABH gel
Given topically
Other Names:
  • Ativan
  • lorazepam
  • diphenhydramine hydrochloride
  • Benadryl
  • Bendylate
  • Eldadryl
  • SK-Diphenhydramine
  • haloperidol
  • Haldol
  • McN-JR-1625
  • R-1625
Other: placebo
Given topically
Other Name: PLCB
Experimental: 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.

Drug: ABH gel
Given topically
Other Names:
  • Ativan
  • lorazepam
  • diphenhydramine hydrochloride
  • Benadryl
  • Bendylate
  • Eldadryl
  • SK-Diphenhydramine
  • haloperidol
  • Haldol
  • McN-JR-1625
  • R-1625
Other: placebo
Given topically
Other Name: PLCB

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556932

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Devon Fletcher Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01556932     History of Changes
Other Study ID Numbers: MCC-14141  NCI-2012-00220 
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

Additional relevant MeSH terms:
Nausea
Signs and Symptoms
Signs and Symptoms, Digestive
Diphenhydramine
Haloperidol
Lorazepam
Promethazine
Anesthetics
Anesthetics, Local
Anti-Allergic Agents
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Dopamine Agents
Dopamine Antagonists
GABA Agents
GABA Modulators
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2016