Nausea, Vomiting
Conditions
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.
Interventions
OTHERplacebo
Given topically
DRUGABH gel
Given topically
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 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. |
Countries
United States
Participant flow
Recruitment details
Participants recruited from Massey Cancer Center, in Richmond City, Virginia USA between March 2012 until May 2013.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Time Point 60 Minutes | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 48.1600 years STANDARD_DEVIATION 14.1500294 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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.
Time frame: 60 minutes after application
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABH Gel | 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 |
| Placebo | The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment. | 0.90 units on a scale | Standard Deviation 2.47 |