Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients
Condition: Oral Cancer; Hypopharyngeal Cancer
MeSH terms: Mouth Neoplasms; Hypopharyngeal Neoplasms; Pharyngeal Neoplasms; Critical Illness
Study type: Interventional

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.
    

Detailed description: 
      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 his 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.

      Other information: The study will be conducted in the surgical ICU department, of china
      medical university hospital, Taichung 404, Taiwan. The study in conducted on stable ICU
      patients and is anticipated to have a minimum risk for adverse events. Patients enrollment
      and data collection will start immediately after china medical hospital research ethics
      committee approval. The study expected completion time: June 2021
    

Intervention name(s): Specific acupuncture group; Metoclopramide 10mg; Non-specific acupuncture group
Intervention type(s): Other; Drug; Other
Intervention description(s): In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by "Yu Kuang" acupuncture needles 40mm with 30G.; Patients in all groups will receive Metoclopramide 10mg/ per 8 hours in the case of poor digestion, alongside the individualized drug treatment prescribed by the ICU medical doctor as per individual patient needs.; Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related conditions, and are not reported to improve digestive function.
Other intervention name(s): Specific acupuncture to treat indigestion; Metoclopramide 10mg/ per 8 hours in the case of poor digestion; Non specific acupuncture to treat indigestion
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups, randomized, pre-post intervention study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Critically ill; Intensive care; Oral cancer; Hypo-pharyngeal cancer; Acupuncture; Digestion; ICU