Alternative Approaches for Nausea Control
2 other identifiers
interventional
242
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2017
CompletedResults Posted
Study results publicly available
May 25, 2018
CompletedJune 26, 2018
May 1, 2018
4.5 years
September 26, 2012
March 27, 2018
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Report Nausea Diary
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.
five days
Study Arms (3)
Arm 1 - Standard Care Only
NO INTERVENTIONPatients will receive standard care only
Arm 2 - Expectancy-neutral Arm
OTHERPatients receive: 1. Expectancy-neutral handout 2. Expectancy-neutral MP3 3. Acupressure bands
Arm 3 - Expectancy-enhancing Arm
EXPERIMENTALPatients receive: 1. Expectancy-enhancing handout 2. Expectancy-enhancing MP3 3. Acupressure bands
Interventions
Bilateral acupressure wrist bands
The expectancy neutral handout has neutral information regarding the acupressure bands
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 expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
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.
Eligibility Criteria
You may qualify if:
- 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:
- Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \& 3.
- Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 \& 3.
- Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, \& 3.
- 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.
You may not qualify if:
- Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
- Be receiving concurrent radiotherapy or interferon.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057, United States
Rochester General Hospital's Lipson Cancer and Blood Center
Rochester, New York, 14621, United States
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph A. Roscoe, PhD Associate Research Professor
- Organization
- University of Rochester Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph A Roscoe, Ph.D.
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
September 26, 2012
First Posted
September 28, 2012
Study Start
November 1, 2012
Primary Completion
May 16, 2017
Study Completion
May 16, 2017
Last Updated
June 26, 2018
Results First Posted
May 25, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share