Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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.
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
SeaBandâ„¢ 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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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