Trial Outcomes & Findings for Alternative Approaches for Nausea Control (NCT NCT01695993)

Last Updated: 2018-06-26

Results Overview

Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The outcome variable for the primary analysis was greatest reported nausea from the five day period.

Recruitment status

COMPLETED

Study phase

Target enrollment

242 participants

Primary outcome timeframe

five days

Results posted on

2018-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Patients receive standard care only	Arm 2 Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component \- Acupressure bands	Arm 3 Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands
Overall Study STARTED	81	80	81
Overall Study COMPLETED	76	75	75
Overall Study NOT COMPLETED	5	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Patients receive standard care only	Arm 2 Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component \- Acupressure bands	Arm 3 Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands
Overall Study Lost to Follow-up	2	1	3
Overall Study Withdrawal by Subject	2	2	2
Overall Study To ill to continue	1	2	0
Overall Study Changed Medical Facility	0	0	1

Baseline Characteristics

Alternative Approaches for Nausea Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=76 Participants Patients will receive only standard care	Arm 2 n=75 Participants * Handout without expectancy- enhancing component * Relaxation MP3 without expectancy-enhancing component * Acupressure bands	Arm 3 n=75 Participants * Handout with expectancy- enhancing component * Relaxation MP3 with expectancy-enhancing component * Acupressure bands	Total n=226 Participants Total of all reporting groups
Age, Continuous	53.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	53.2 years STANDARD_DEVIATION 11.6 • n=7 Participants	52.6 years STANDARD_DEVIATION 10.5 • n=5 Participants	53 years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	75 Participants n=7 Participants	75 Participants n=5 Participants	226 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	74 Participants n=7 Participants	73 Participants n=5 Participants	220 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) White	67 Participants n=5 Participants	66 Participants n=7 Participants	66 Participants n=5 Participants	199 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	76 participants n=5 Participants	75 participants n=7 Participants	75 participants n=5 Participants	226 participants n=4 Participants

PRIMARY outcome

Timeframe: five days

Outcome measures

Outcome measures
Measure	Standard Care n=76 Participants Patients receive only standard care	Expectancy-Neutral Condition n=75 Participants * Handout without expectancy- enhancing component * Relaxation MP3 without expectancy-enhancing component * Acupressure bands	Expectancy-Enhancing Condition n=75 Participants * Handout with expectancy-enhancing component * Relaxation MP3 with expectancy-enhancing component * Acupressure bands
Patient Report Nausea Diary	3.87 units on a scale Standard Deviation 2.00	3.55 units on a scale Standard Deviation 2.00	3.52 units on a scale Standard Deviation 1.73

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph A. Roscoe, PhD Associate Research Professor

University of Rochester Medical Center

Phone: 585 275-9962

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place