Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy

NCT ID: NCT00978185

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 699 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-10-31

Brief Summary

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.

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.

Conditions

Anxiety Disorder; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomiting; anxiety disorder; unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

medical chart review

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

acupressure therapy

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

sham intervention

Intervention Type: PROCEDURE

standard follow-up care

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Principal Investigators

Alex Molassiotis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

University of Manchester

Manchester, England, United Kingdom

Countries

United Kingdom

Other Identifiers

UM-ACMCN

Identifier Type: -

Identifier Source: secondary_id

EU-20971

Identifier Type: -

Identifier Source: secondary_id

CDR0000649812

Identifier Type: -

Identifier Source: org_study_id