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Alternative Approaches for Nausea Control

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ClinicalTrials.gov Identifier: NCT01695993
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : May 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Nausea
Interventions Device: Acupressure bands
Other: Expectancy-neutral handout
Behavioral: Expectancy-neutral MP3
Other: Expectancy-enhancing handout
Behavioral: Expectancy-enhancing MP3
Enrollment 242

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description Patients receive standard care only

Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component

- Acupressure bands

Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands
Period Title: Overall Study
Started 81 80 81
Completed 76 75 75
Not Completed 5 5 6
Reason Not Completed
Lost to Follow-up             2             1             3
Withdrawal by Subject             2             2             2
To ill to continue             1             2             0
Changed Medical Facility             0             0             1
Arm/Group Title Arm 1 Arm 2 Arm 3 Total
Hide Arm/Group Description Patients will receive only standard care
  • Handout without expectancy- enhancing component
  • Relaxation MP3 without expectancy-enhancing component
  • Acupressure bands
  • Handout with expectancy- enhancing component
  • Relaxation MP3 with expectancy-enhancing component
  • Acupressure bands
Total of all reporting groups
Overall Number of Baseline Participants 76 75 75 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 75 participants 75 participants 226 participants
53.2  (11.5) 53.2  (11.6) 52.6  (10.5) 53  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 75 participants 226 participants
Female
76
 100.0%
75
 100.0%
75
 100.0%
226
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 75 participants 226 participants
Hispanic or Latino
3
   3.9%
1
   1.3%
1
   1.3%
5
   2.2%
Not Hispanic or Latino
73
  96.1%
74
  98.7%
73
  97.3%
220
  97.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 75 participants 226 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   1.3%
2
   0.9%
Asian
2
   2.6%
1
   1.3%
1
   1.3%
4
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   9.2%
6
   8.0%
6
   8.0%
19
   8.4%
White
67
  88.2%
66
  88.0%
66
  88.0%
199
  88.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.3%
1
   1.3%
2
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 75 participants 75 participants 226 participants
76 75 75 226
1.Primary Outcome
Title Patient Report Nausea Diary
Hide Description 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.
Time Frame five days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Expectancy-Neutral Condition Expectancy-Enhancing Condition
Hide Arm/Group Description:
Patients receive only standard care
  • Handout without expectancy- enhancing component
  • Relaxation MP3 without expectancy-enhancing component
  • Acupressure bands
  • Handout with expectancy-enhancing component
  • Relaxation MP3 with expectancy-enhancing component
  • Acupressure bands
Overall Number of Participants Analyzed 76 75 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.87  (2.00) 3.55  (2.00) 3.52  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Expectancy-Neutral Condition, Expectancy-Enhancing Condition
Comments [Not Specified]
Type of Statistical Test Other
Comments Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.
Statistical Test of Hypothesis P-Value .05
Comments Not adjusted
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Parameter Dispersion
Type: Standard Deviation
Value: 1.9
Estimation Comments [Not Specified]
Time Frame two months
Adverse Event Reporting Description We used a standard definition for adverse events, but because this was a minimal risk study, our IRB required us to report and record only SAEs that were possibly, probably, or definitely related to the study intervention. See Section 5.7.1.1 of the protocol.
 
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description Patients will receive only standard care

Patients receive:

  1. Handout without expectancy- enhancing component
  2. Relaxation MP3 without expectancy-enhancing component
  3. Acupressure bands

Patients receive:

  1. Handout with expectancy- enhancing component
  2. Relaxation MP3 with expectancy-enhancing component
  3. Acupressure bands
All-Cause Mortality
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/75 (0.00%)   0/75 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/75 (0.00%)   0/75 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/75 (0.00%)   0/75 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joseph A. Roscoe, PhD Associate Research Professor
Organization: University of Rochester Medical Center
Phone: 585 275-9962
Responsible Party: Joseph Roscoe, University of Rochester
ClinicalTrials.gov Identifier: NCT01695993     History of Changes
Other Study ID Numbers: UCCS1202
R01AT007474-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2012
First Posted: September 28, 2012
Results First Submitted: March 27, 2018
Results First Posted: May 25, 2018
Last Update Posted: June 25, 2018