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Alternative Approaches for Nausea Control

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Alternative Approaches for Nausea Control

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

patient report nausea diary

Outcome Description:

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.

Outcome Time Frame:

five days

Safety Issue:


Principal Investigator

Joseph A Roscoe, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Data and Safety Monitoring Board

Study ID:




Start Date:

November 2012

Completion Date:

May 2017

Related Keywords:

  • Nausea
  • Nausea
  • Quality of life
  • Chemotherapy
  • Expectancy
  • Nausea



Roswell Park Cancer Institute Buffalo, New York  14263
University of Rochester James P. Wilmot Cancer Center Rochester, New York  14642
Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Rochester General Hospital's Lipson Cancer and Blood Center Rochester, New York  14621