Alternative Approaches for Nausea Control

Alternative Approaches for Nausea Control

Sponsors

Lead sponsor: University of Rochester

Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Source 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

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.

Overall Status Completed
Start Date November 2012
Completion Date May 16, 2017
Primary Completion Date May 16, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient Report Nausea Diary five days
Enrollment 242
Condition
Intervention

Intervention type: Device

Intervention name: Acupressure bands

Description: Bilateral acupressure wrist bands

Intervention type: Other

Intervention name: Expectancy-neutral handout

Description: The expectancy neutral handout has neutral information regarding the acupressure bands

Arm group label: Arm 2 - Expectancy-neutral Arm

Intervention type: Behavioral

Intervention name: Expectancy-neutral MP3

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.

Arm group label: Arm 2 - Expectancy-neutral Arm

Intervention type: Other

Intervention name: Expectancy-enhancing handout

Description: The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands

Arm group label: Arm 3 - Expectancy-enhancing Arm

Intervention type: Behavioral

Intervention name: Expectancy-enhancing MP3

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.

Arm group label: Arm 3 - Expectancy-enhancing Arm

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:

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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Joseph A Roscoe, Ph.D. Principal Investigator University of Rochester
Location
facility
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
Location Countries

United States

Verification Date

May 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Rochester

Investigator full name: Joseph Roscoe

Investigator title: Research Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Arm 1 - Standard Care Only

Arm group type: No Intervention

Description: Patients will receive standard care only

Arm group label: Arm 2 - Expectancy-neutral Arm

Arm group type: Other

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

Arm group label: Arm 3 - Expectancy-enhancing Arm

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov