Trial record 1 of 1 for:    NCT01695993
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Alternative Approaches for Nausea Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 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: January 6, 2014
Last verified: January 2014

September 26, 2012
January 6, 2014
November 2012
February 2017   (final data collection date for primary outcome measure)
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.
patient report nausea diary [ Time Frame: five days ] [ Designated as safety issue: No ]
Nausea and emesis will be measured by a patient report diary developed by Burish38 and Carey39 and 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 (20 total reporting times for each five-day period). 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 as part of the five-day diary for later exploratory analyses. We have used this scale in previous studies,7,13,40 so we will be able to compare current findings with results of our previous research.
Complete list of historical versions of study NCT01695993 on ClinicalTrials.gov Archive Site
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Alternative Approaches for Nausea Control
Alternative Approaches for Nausea Control

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Nausea
  • 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.
  • 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.
  • 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.
    Interventions:
    • Device: Acupressure bands
    • Other: Version 1 handout
    • Behavioral: Version 1 MP3
  • Experimental: Arm 3
    Patients will receive the Version 2 handout, the Version 2 MP3, and acupressure bands.
    Interventions:
    • Device: Acupressure bands
    • Other: Version 2 handout
    • Behavioral: Version 2 MP3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
216
May 2017
February 2017   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Jenine Hoefler, M.S. 585.276.3559 Jenine_Hoefler@URMC.Rochester.edu
United States
 
NCT01695993
UCCS1202, R01AT007474-01A1
Yes
Joseph Roscoe, University of Rochester
University of Rochester
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Joseph A Roscoe, Ph.D. University of Rochester
University of Rochester
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP