Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hong Kong Polytechnic University
• Treatments: Antiemetics; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Emetics

Criteria

Inclusion Criteria:

• Adult female patients aged above 18 years old;

• A diagnosis of breast cancer stage I-III;

• Chemotherapy- naive;

• Auricular therapy-naive;

• Be able to communicate in Chinese mandarin;

• Have at least completed a primary school education;

• Agree to participate in the study and be willing to give written informed consent;

• Be scheduled to receive the first cycle of chemotherapy with moderately-high to highly emetogenic potentials;

• Be provided with standard antiemetic medications during chemotherapy.

Exclusion Criteria:

• Extremely weak, disabled or immunocompromised cancer patients;

• Be unable to follow the study instructions to do AT intervention or other research procedures;

• Have concurrent radiotherapy or other kinds of antineoplastic therapy;

• Currently take part in clinical studies on anti-emetic medications or other kinds of non-pharmacological interventions to control CINV, or other studies which are believed to produce potential interactions with this AT trial;

• Have other health problems which may affect the symptoms of CINV such as gastrointestinal disease, liver disease, migraine, tinnitus and Ménière's disease, etc.;

• Ear skin problems which are not appropriate for auricular acupressure including ear infections, ear scars and rashes, ear frostbite, and ear abscess, etc.