Trial Information

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

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.