Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy

August 23, 2013 updated by: University of Manchester

The Effectiveness and Cost Effectiveness of Acupressure for the Control and Management of Chemotherapy-related Nausea.

RATIONALE: Acupressure wristbands may prevent or reduce nausea caused by chemotherapy. It is not yet known whether acupressure wristbands are more effective than standard care in controlling acute and delayed nausea.

PURPOSE: This randomized phase III trial is studying acupressure wristbands to see how well they work compared with standard care in controlling nausea caused by chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES:

Primary

  • To assess the clinical effectiveness of self-acupressure using wristbands in addition to standard care in the management of chemotherapy-induced (acute and delayed) nausea compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.

Secondary

  • To assess the cost effectiveness and extent of use of usual care in patients using acupressure wristbands in addition to standard care for the management of chemotherapy-induced nausea compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.
  • To assess the level of quality of life in patients using acupressure and standard care alone.
  • To assess the clinical effectiveness of self-acupressure using wristbands in addition to standard care in the management of chemotherapy-induced (acute and delayed) vomiting compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.
  • To ascertain for which emetogenic level of chemotherapy regimens (i.e., high, moderate, or low emetogenic chemotherapy) self-acupressure using wristbands in addition to standard care is more or less effective in terms of nausea compared to patients receiving standard care with sham-acupressure wristbands and standard care alone.
  • To ascertain whether any improvement in chemotherapy-induced nausea and vomiting from using acupressure wristbands is different in males and females.
  • To ascertain whether there is an age effect from the use of acupressure wristbands in relation to chemotherapy-induced nausea and vomiting.

OUTLINE: Patients are stratified according to gender, age in years (16 to 24 vs >24 to 50 vs > 50), and level of emetogenic chemotherapy (high vs moderate vs low). Patients are randomized to 1 of 3 intervention arms:

  • Arm I (acupressure group): Patients receive standard antiemetics comprising an oral 5-HT3 receptor antagonist (i.e., Zofran) and oral or IV dexamethasone before and for 3 days post-chemotherapy (for highly emetic chemotherapy); an oral 5-HT3 receptor antagonist (i.e., Zofran) and dexamethasone IV before chemotherapy and a 5-HT3 receptor antagonist or dexamethasone for 2 days post-chemotherapy (for moderately emetogenic chemotherapy); or oral dexamethasone before chemotherapy (for low-emetogenic chemotherapy). Beginning on the morning before chemotherapy, patients wear a pair of SeaBand™ elastic wristbands on each arm for 7 days. Each wristband has a 1-cm protruding round plastic button (stud) pressing the P6 acupoint, located on the anterior surface of the forearm, approximately three-finger width up from the crease of the wrist between the tendons of the Palmaris longus and flexor carpi radialis.
  • Arm II (sham acupressure group): Patients receive standard antiemetics as in arm I. Beginning on the morning before chemotherapy, patients wear a pair of elastic wristbands on each arm for 7 days. Each wristband has a flat button pressing the P6 acupoint, located on the anterior surface of the forearm, approximately three-finger width up from the crease of the wrist between the tendons of the Palmaris longus and flexor carpi radialis.
  • Arm III (control group): Patients receive standard antiemetics as in arm I. Patients are assessed periodically by questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
699

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Manchester, England, United Kingdom, M13 9PL
        • University of Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of any cancer

    • Scheduled to receive their first chemotherapy course
    • Scheduled to receive highly, moderately, or low-emetogenic chemotherapy
    • Scheduled to receive a chemotherapy regimen given as a single administration at the beginning of the course repeated in 3-week courses
  • Currently receiving adjuvant chemotherapy as outpatient
  • Acupressure wristband-naïve (in terms of never having tried such a wristband; may have seen or heard about such wristbands)

PATIENT CHARACTERISTICS:

  • Able to perform self care (i.e., no inability to use wristbands appropriately or mental incapacity preventing continuous and optimal use of wristbands) as judged by the investigators
  • No liver disease
  • No metabolic risk factors for nausea (i.e., electrolyte imbalances causing nausea/vomiting)
  • No mechanical risk factors for nausea (i.e., intestinal obstruction)
  • No nausea and/or vomiting due to use of opioids
  • No lymphedematous arms
  • No chronic alcohol use

PRIOR CONCURRENT THERAPY:

  • No concurrent radiotherapy
  • No concurrent chemotherapy regimens as inpatients

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Incidence and severity of nausea as assessed by the Rhodes Index of Nausea & Vomiting before and after chemotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Incidence and extent of acute and delayed nausea and vomiting by the MASCC Antiemesis Tool at day 10 of each course
Quality of life as assessed by FACT-G at baseline and at day 10 of each course
Anxiety as assessed by the Hospital Anxiety & Depression Scale at baseline
Expectation for nausea and vomiting as assessed by the Patient Expectations of Nausea/Vomiting after each chemotherapy course
Measure of blindness (to intervention vs sham) assessed after chemotherapy
Sociodemographic and treatment characteristics assessed at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDR0000649812
  • UM-ACMCN
  • EU-20971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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