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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 : May 25, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester

September 26, 2012
September 28, 2012
March 27, 2018
May 25, 2018
May 25, 2018
November 2012
May 16, 2017   (Final data collection date for primary outcome measure)
Patient Report Nausea Diary [ Time Frame: five days ]
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.
Patient Report Nausea Diary [ Time Frame: five days ]
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
Not Provided
Not Provided
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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: 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

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: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing 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
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Nausea
  • 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.
  • No Intervention: Arm 1 - Standard Care Only
    Patients will receive standard care only
  • Arm 2 - Expectancy-neutral Arm

    Patients receive:

    1. Expectancy-neutral handout
    2. Expectancy-neutral MP3
    3. Acupressure bands
    Interventions:
    • Device: Acupressure bands
    • Other: Expectancy-neutral handout
    • Behavioral: Expectancy-neutral MP3
  • Experimental: Arm 3 - Expectancy-enhancing Arm

    Patients receive:

    1. Expectancy-enhancing handout
    2. Expectancy-enhancing MP3
    3. Acupressure bands
    Interventions:
    • Device: Acupressure bands
    • Other: Expectancy-enhancing handout
    • Behavioral: Expectancy-enhancing MP3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
216
May 16, 2017
May 16, 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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01695993
UCCS1202
R01AT007474-01A1 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Joseph Roscoe, University of Rochester
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Joseph A Roscoe, Ph.D. University of Rochester
University of Rochester
March 2018

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