Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients
Status:
Completed
Trial end date:
2021-03-19
Target enrollment:
Participant gender:
Summary
Background: Head and neck cancer patients are in high risk to suffer from malnourishment, a
risk that increase in postoperative condition and with the use of enteral nutrition (EN).
Until now patients who are suffering from indigestion in the ICU received treatment in the
form of prokinetic drugs, drags that can lead to serious side effects and only can partially
improve digestion. Acupuncture was used successfully in several clinical trials to improve
postoperative indigestion in cancer patients without any reported adverse events. This study
aims is to design a double blind settings in order to investigate acupuncture effect in
combination of prokinetic drugs in the prevention of indigestion in postoperative oral and
hypo-pharyngeal cancer patients in the Intensive Care Unit (ICU).
Methods: Single center, double blind randomize control trial will compare between two equal
groups. A total of 28 patients that will meet the inclusion criteria: Age 30-80, Post plastic
surgery for oral cancer or hypo-pharyngeal cancer, Apache score below 20 needed EN. Patients
will be randomly divided into specific acupuncture (ACU) or non-specific acupuncture (CON)
for 3 treatments in 3 days by a blind acupuncturist along with prokinetic drugs. The main
outcome measurement will be the amount of days a patient need to reach Total Energy
Expenditure (TEE).
Expected outcome: The results will shed light on the effectiveness and safety of acupuncture
in a double blind design for posts-surgery ICU cancer patients. In addition, the study
presents a revolutionary double blind design that if will prove as successful might influence
the way double blind acupuncture studies are performed today.