Alternative Approaches for Nausea Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester
ClinicalTrials.gov Identifier:
NCT01695993
First received: September 26, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Nausea
Device: Acupressure bands
Other: Version 1 handout
Behavioral: Version 1 MP3
Other: Version 2 handout
Behavioral: Version 2 MP3
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Alternative Approaches for Nausea Control

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • patient report nausea diary [ Time Frame: five days ] [ Designated as safety issue: No ]
    Nausea and emesis 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." Vomiting episodes will be recorded for the same time intervals.


Estimated Enrollment: 216
Study Start Date: November 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Patients will receive only the Version 1 handout.
Arm 2
Patients will receive the Version 1 handout, the Version 1 MP3, and acupressure bands.
Device: Acupressure bands
Bilateral 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 handout
The Version 1 handout has less information concerning the acupressure bands than the Version 2 handout.
Behavioral: Version 1 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.
Experimental: Arm 3
Patients will receive the Version 2 handout, the Version 2 MP3, and acupressure bands.
Device: Acupressure bands
Bilateral 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 2 handout
The Version 2 handout has more information concerning the acupressure bands than the Version 1 handout.
Behavioral: Version 2 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. The MP3 (for subjects randomized to Arm 3) has some additional information in it regarding relaxation.

Detailed Description:

Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: Version 1 of Handout; Arm 2: Version 1 of handout + Version 1 relaxation MP3 + acupressure bands; Arm 3: Version 2 of handout + Version 2 of relaxation MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be female.
  • Have a diagnosis of breast cancer, any stage.
  • Be chemotherapy naïve and about to begin her first course of chemotherapy.
  • Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are:

    1. Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
    2. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3.
    3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
    4. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.

Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.

  • Have a response of > 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = "I am certain I WILL NOT have this," and at the other end by 5 = "I am certain I WILL have this."
  • Be able to read English (since the assessment materials are in printed format).
  • Be 18 years of age or older and give written informed consent.

Exclusion Criteria:

  • Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
  • Be receiving concurrent radiotherapy or interferon.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695993

Contacts
Contact: Jenine Hoefler, M.S. 585.276.3559 Jenine_Hoefler@URMC.Rochester.edu

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Mary Lynne Tarquini, RN, BSN, CCRP Tarquini, RN, BSN, C    716-845-3008    cab21@healthresearch.org   
Contact: Roswell Park    877-275-7724    ASKRPCI@RoswellPark.org   
Principal Investigator: Tracey O'Connor, M.D.         
Hematology-Oncology Associates of Central New York Recruiting
East Syracuse, New York, United States, 13057
Contact: Coleen A Dillenbeck, MA, CCRC    315-472-7504 ext 1360    cdillenbeck@hoacny.com   
Principal Investigator: Jeffrey J. Kirshner, M.D.         
University of Rochester James P. Wilmot Cancer Center Recruiting
Rochester, New York, United States, 14642
Contact: Jenine Hoefler, M.S.    585-276-3559    Jenine_Hoefler@URMC.Rochester.edu   
Principal Investigator: Joseph A Roscoe, Ph.D.         
Rochester General Hospital's Lipson Cancer and Blood Center Recruiting
Rochester, New York, United States, 14621
Contact: Caroline Andrews, MBA, CCRC    585-922-4040    Caroline.Andrews@rochestergeneral.org   
Principal Investigator: Peter Bushunow, M.D.         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Joseph A Roscoe, Ph.D. University of Rochester
  More Information

No publications provided

Responsible Party: Joseph Roscoe, Research Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01695993     History of Changes
Other Study ID Numbers: UCCS1202, R01AT007474-01A1
Study First Received: September 26, 2012
Last Updated: August 6, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Rochester:
Nausea
Quality of life
Chemotherapy
Expectancy

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014