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Alternative Approaches for Nausea Control

NCT01695993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2018-06-26

Study results available
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Summary

216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.

Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea

Conditions

Interventions

DEVICE

Acupressure bands

Bilateral acupressure wrist bands

OTHER

Expectancy-neutral handout

The expectancy neutral handout has neutral information regarding the acupressure bands

BEHAVIORAL

Expectancy-neutral MP3

Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.

OTHER

Expectancy-enhancing handout

The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands

BEHAVIORAL

Expectancy-enhancing MP3

Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Joseph A Roscoe, Ph.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-05-16
Completion
2017-05-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695993 on ClinicalTrials.gov