Completed

Alternative Approaches for Nausea Control

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Acupressure bands

+ Expectancy-neutral handout

+ Expectancy-neutral MP3

DeviceOtherBehavioral
Who is being recruted

Signs and Symptoms+1

+ Signs and Symptoms, Digestive

+ Pathological Conditions, Signs and Symptoms

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity of Rochester
Last updated: June 26, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01695993
Principal SponsorUniversity of Rochester
Last updated: June 26, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

242 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsNausea

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Patients will receive standard care only

Group II

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

Group III

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Roswell Park Cancer Institute

Buffalo, United StatesOpen Roswell Park Cancer Institute in Google Maps

Hematology-Oncology Associates of Central New York

East Syracuse, United States

Rochester General Hospital's Lipson Cancer and Blood Center

Rochester, United States

University of Rochester James P. Wilmot Cancer Center

Rochester, United States
Completed4 Study Centers