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Alternative Approaches for Nausea Control

Primary Purpose

Nausea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupressure bands
Expectancy-neutral handout
Expectancy-neutral MP3
Expectancy-enhancing handout
Expectancy-enhancing MP3
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea focused on measuring Nausea, Quality of life, Chemotherapy, Expectancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Roswell Park Cancer Institute
  • Hematology-Oncology Associates of Central New York
  • Rochester General Hospital's Lipson Cancer and Blood Center
  • University of Rochester James P. Wilmot Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Experimental

Arm Label

Arm 1 - Standard Care Only

Arm 2 - Expectancy-neutral Arm

Arm 3 - Expectancy-enhancing Arm

Arm Description

Patients will receive standard care only

Patients receive: Expectancy-neutral handout Expectancy-neutral MP3 Acupressure bands

Patients receive: Expectancy-enhancing handout Expectancy-enhancing MP3 Acupressure bands

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2012
Last Updated
May 24, 2018
Sponsor
University of Rochester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01695993
Brief Title
Alternative Approaches for Nausea Control
Official Title
Alternative Approaches for Nausea Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
May 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea
Keywords
Nausea, Quality of life, Chemotherapy, Expectancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Standard Care Only
Arm Type
No Intervention
Arm Description
Patients will receive standard care only
Arm Title
Arm 2 - Expectancy-neutral Arm
Arm Type
Other
Arm Description
Patients receive: Expectancy-neutral handout Expectancy-neutral MP3 Acupressure bands
Arm Title
Arm 3 - Expectancy-enhancing Arm
Arm Type
Experimental
Arm Description
Patients receive: Expectancy-enhancing handout Expectancy-enhancing MP3 Acupressure bands
Intervention Type
Device
Intervention Name(s)
Acupressure bands
Intervention Description
Bilateral acupressure wrist bands
Intervention Type
Other
Intervention Name(s)
Expectancy-neutral handout
Intervention Description
The expectancy neutral handout has neutral information regarding the acupressure bands
Intervention Type
Behavioral
Intervention Name(s)
Expectancy-neutral MP3
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Expectancy-enhancing handout
Intervention Description
The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
Intervention Type
Behavioral
Intervention Name(s)
Expectancy-enhancing MP3
Intervention Description
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 Measure Information:
Title
Patient Report Nausea Diary
Description
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.
Time Frame
five days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Roscoe, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Rochester General Hospital's Lipson Cancer and Blood Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
University of Rochester James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Alternative Approaches for Nausea Control

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