Alternative Approaches for Nausea Control

Nausea Clinical Trial

Official title:

Alternative Approaches for Nausea Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695993
• Other study ID #: UCCS1202
• Secondary ID: R01AT007474-01A1
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: May 16, 2017

Study information

• Verified date: May 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nausea

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Rochester General Hospital's Lipson Cancer and Blood Center	Rochester	New York
United States	University of Rochester James P. Wilmot Cancer Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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