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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

Brief 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


Condition or disease Intervention/treatment Phase
Nausea Device: Acupressure bands Other: Expectancy-neutral handout Behavioral: Expectancy-neutral MP3 Other: Expectancy-enhancing handout Behavioral: Expectancy-enhancing MP3 Not Applicable

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: 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Alternative Approaches for Nausea Control
Actual Study Start Date : November 2012
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : May 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

Experimental: Arm 3 - Expectancy-enhancing Arm

Patients receive:

  1. Expectancy-enhancing handout
  2. Expectancy-enhancing MP3
  3. Acupressure bands
Device: Acupressure bands
Bilateral acupressure wrist bands

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695993


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Rochester General Hospital's Lipson Cancer and Blood Center
Rochester, New York, United States, 14621
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Joseph A Roscoe, Ph.D. University of Rochester
  Study Documents (Full-Text)

Documents provided by Joseph Roscoe, University of Rochester:

Responsible Party: Joseph Roscoe, Research Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01695993     History of Changes
Other Study ID Numbers: UCCS1202
R01AT007474-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2012    Key Record Dates
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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