Introduction: Despite improvements in antiemetic therapy, chemotherapy induced nausea and vomiting (CINV) continues to be a common side effect impacting on quality of life for cancer patients. A Cochrane review (1) has shownthat acupuncture reduces the incidence of acute vomiting but not acute or delayed nausea. Electroacupuncture (EA) reduced acute vomiting, but delayed symptoms were not reported and standard antiemetics were not used. To prepare for a high quality controlled study to determine whether EA gives better control of delayed CINV than standard antiemetic treatment alone, we undertook a pilot study.
Methods: Patients having their first cycle of moderately or highly emetogenic chemotherapy were approached. Patients were randomised to one of three arms; EA, sham EA or standard care. EA was given for 30 minutes on day 1 of chemo and on day 3 using standard acupuncture points bilaterally. Sham EA was given to points adjacent to true EA points. All patients received antiemetics according to hospital guidelines. A daily diary rating nausea and vomiting for 7 days and the Functional Living Index Emesis (FLIE) was captured on Days 1, 4 and 7.
Results: Sixty patients were recruited from April 2009 to May 2011. The FLIE was completed by 49 of 60 patients, on days 4 and 7. Adverse events were generally mild and infrequent (needle pain, bruising). There was no difference in nausea scores between arms but scores were low in all 3 arms.
Discussion: Our pilot study confirmed the feasibility of a definitive study and improvements in design. As few patients experienced nausea with their 1stcycle of chemotherapy, we will recruit at their 2nd or 3rd cycle using an enriched enrolment design (only if they experienced CINV in their 1st course). As QoL aspects of the FLIE could dilute the objective nausea scores, a NRS scoring nausea as the primary end-point will be used with the FLIE as a secondary outcome measure. As participants come back for a second course, acupuncture will be delivered on days 1 and 3 as standard.