Nausea | Alternative Approaches for Nausea Control
Nausea research study
What is the primary objective of this study?
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: Version 1 handout; Arm 2: Version 1 handout + Version 1 relaxation MP3 + acupressure bands; Arm 3: Version 2 handout + Version 2 relaxation MP3 + acupressure bands. Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Acupressure bandsBilateral acupressure wrist bands (Sea-Band International, England), given to patients in trial Arms 2 and 3, are widely available and inexpensive (under $6.00 a pair).
Other:Version 1 handoutThe Version 1 handout has less information concerning the acupressure bands than the Version 2 handout.
Behavioral:Version 1 MP3Patients 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:Version 2 handoutThe Version 2 handout has more information concerning the acupressure bands than the Version 1 handout.
Behavioral:Version 2 MP3Patients 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. The MP3 (for subjects randomized to Arm 3) has some additional information in it regarding relaxation.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm 1Patients will receive only the Version 1 handout.
Arm 2Patients will receive the Version 1 handout, the Version 1 MP3, and acupressure bands.
Arm 3Patients will receive the Version 2 handout, the Version 2 MP3, and acupressure bands.
Start Date: November 2012
Completed Date: May 16, 2017
Primary Outcome: patient report nausea diary
Study sponsors, principal investigator, and references
Principal Investigator: Joseph A Roscoe, Ph.D.
Lead Sponsor: University of Rochester
Collaborator: National Center for Complementary and Integrative Health (NCCIH)