Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorder Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific	Other: medical chart review Other: questionnaire administration Procedure: acupressure therapy Procedure: quality-of-life assessment Procedure: sham intervention Procedure: standard follow-up care	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
Official Title:	The Effectiveness and Cost Effectiveness of Acupressure for the Control and Management of Chemotherapy-related Nausea.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Nausea and Vomiting

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence and severity of nausea as assessed by the Rhodes Index of Nausea & Vomiting before and after chemotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence and extent of acute and delayed nausea and vomiting by the MASCC Antiemesis Tool at day 10 of each course [ Designated as safety issue: No ]
Quality of life as assessed by FACT-G at baseline and at day 10 of each course [ Designated as safety issue: No ]
Anxiety as assessed by the Hospital Anxiety & Depression Scale at baseline [ Designated as safety issue: No ]
Expectation for nausea and vomiting as assessed by the Patient Expectations of Nausea/Vomiting after each chemotherapy course [ Designated as safety issue: No ]
Measure of blindness (to intervention vs sham) assessed after chemotherapy [ Designated as safety issue: No ]
Sociodemographic and treatment characteristics assessed at baseline [ Designated as safety issue: No ]

Estimated Enrollment:	699
Study Start Date:	November 2008
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978185

Locations

United Kingdom
University of Manchester	Recruiting
Manchester, England, United Kingdom, M13 9PL
Contact: Alex Molassiotis, MD 44-161-306-7830

Sponsors and Collaborators

University of Manchester

Investigators

Principal Investigator:

Alex Molassiotis, MD

University of Manchester

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00978185 History of Changes
Other Study ID Numbers:	CDR0000649812, UM-ACMCN, EU-20971
Study First Received:	September 15, 2009
Last Updated:	November 10, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Anxiety Disorders
Nausea
Vomiting

Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013