Alternative Approaches for Nausea Control

• ClinicalTrials.gov Identifier: NCT01695993
• Recruitment Status: Completed
• First Posted: September 28, 2012
• Results First Posted: May 25, 2018
• Last Update Posted: June 26, 2018
• Sponsor: University of Rochester
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Joseph Roscoe, University of Rochester

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

Condition or disease	Intervention/treatment	Phase
Nausea	Device: Acupressure bands; Other: Expectancy-neutral handout; Behavioral: Expectancy-neutral MP3; Other: Expectancy-enhancing handout; Behavioral: Expectancy-enhancing MP3	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Alternative Approaches for Nausea Control
• Actual Study Start Date: November 2012
• Actual Primary Completion Date: May 16, 2017
• Actual Study Completion Date: May 16, 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Arm 1 - Standard Care Only; Patients will receive standard care only
Arm 2 - Expectancy-neutral Arm; Patients receive: Expectancy-neutral handout; Expectancy-neutral MP3; Acupressure bands	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.
Experimental: Arm 3 - Expectancy-enhancing Arm; Patients receive: Expectancy-enhancing handout; Expectancy-enhancing MP3; Acupressure bands	Device: Acupressure bands; Bilateral acupressure wrist bands; 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.

Outcome Measures

Primary Outcome Measures :

1. Patient Report Nausea Diary [ Time Frame: five days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States, 13057

Rochester General Hospital's Lipson Cancer and Blood Center

Rochester, New York, United States, 14621

University of Rochester James P. Wilmot Cancer Center

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Joseph A Roscoe, Ph.D.; University of Rochester

  Study Documents (Full-Text)

Documents provided by Joseph Roscoe, University of Rochester:

Study Protocol and Statistical Analysis Plan  [PDF] January 26, 2016

More Information

• Responsible Party: Joseph Roscoe, Research Associate Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01695993
• Other Study ID Numbers: UCCS1202; R01AT007474-01A1 ( U.S. NIH Grant/Contract )
• First Posted: September 28, 2012
• Results First Posted: May 25, 2018
• Last Update Posted: June 26, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph Roscoe, University of Rochester:

Nausea; Quality of life; Chemotherapy; Expectancy

Additional relevant MeSH terms:

Nausea; Signs and Symptoms, Digestive