Breast Neoplasms Clinical Trial
Official title:
The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial
To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial
using a standard auricular acupressure protocol for managing nausea and vomiting in a
homogenous group of female breast cancer patients undergoing chemotherapy.
The null hypotheses of this study are: (1) There will be no significant difference in
acute/delayed nausea and vomiting among groups during the intervention period; (2) There
will be no significant difference in anticipatory nausea and vomiting among groups before
the second cycle of chemotherapy; (3) There will be no significant difference in quality of
life status among groups at the end of the first cycle of chemotherapy.
Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing
side-effects among cancer patients undergoing chemotherapy. Despite steady progresses in
antiemetic prophylaxis and treatment during the past decades, approximately half of cancer
patients receiving moderately to highly emetogenic chemotherapy still experience significant
nausea and vomiting. Considering the facts that CINV is difficult to be completely
controlled by antiemetics along, healthcare professionals has explored the role of
non-pharmacological interventions as adjunctive therapy for controlling CINV. Among which,
auricular therapy (AT) is a promising approach but the evidence has still not been
concluded.
The aim of this study is to test the feasibility of a randomized controlled trial using
auricular acupressure protocol for managing nausea and vomiting in female breast cancer
patients undergoing chemotherapy. The objectives of this study will be: (1) to pilot the
methodological procedure of the randomized controlled trial using a standard auricular
acupressure protocol for controlling CINV; (2) to determine the recruitment rate and
attrition rate during the whole study period; (3) to determine the feasibility of the study
questionnaires and auricular acupressure protocol to the study participants; (4) to identify
potential adverse events associated with auricular acupressure; (5) to preliminarily examine
the effects of auricular acupressure on CINV and QoL in female breast cancer patients
receiving chemotherapy; (6) to explore patients' experience in completing the trial and
receiving the intervention; and (7) to refine the study protocol for a future multicenter,
large-scale randomized controlled trial.
A three-parallel-arm, placebo-controlled randomized pilot study will be adopted. One hundred
and fourteen breast cancer patients scheduled to receive the first cycle of chemotherapy
will be recruited from three provincial hospitals in Fuzhou, China, and will be randomly
assigned to one of the three groups: the true AT group, the sham AT group or the standard
care group. Participants in the true AT group will receive standard anti-emetic medications
plus a 5-day auricular acupressure at the specific ear acupoints, participants in the sham
AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at
the same acupoints as in the true AT group without any acupoint stimulation, while
participants in the standard care group will only be provided with the standard anti-emetic
medications. The feasibility outcomes will be the recruitment rate and consent rate during
the recruitment stage, the attrition rate during the whole study period, feasibility of the
study questionnaires and auricular acupressure protocol to the study participants, and
AT-related adverse events. The future main study outcomes will also be measured including
acuteCINV, delayed CINV, anticipatory CINV, and quality of life. After completing the pilot
clinical trial, a nested qualitative interview will be conducted to explore participants'
experience in completing the trial and receiving the intervention.
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