Acupressure Wristbands or Standard Care in Controlling Nausea Caused by Chemotherapy

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: medical chart review
* Other: questionnaire administration
* Procedure: acupressure therapy
* Procedure: quality-of-life assessment
* Procedure: sham intervention
* Procedure: standard follow-up care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: medical chart review|nan|
|Other: questionnaire administration|nan|
|Procedure: acupressure therapy|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: sham intervention|nan|
|Procedure: standard follow-up care|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of nausea as assessed by the Rhodes Index of Nausea & Vomiting before and after chemotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, anxiety disorder, unspecified adult solid tumor, protocol specific