Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

China Medical University

Status: Completed

Conditions: Oral Cancer; Hypopharyngeal Cancer

Treatments: Drug: Metoclopramide 10mg; Other: Non-specific acupuncture group; Other: Specific acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT03934294

CMUH108-REC2-037(AR-1)

Details and patient eligibility

About

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.

Full 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

Enrollment: 28 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30-80
• Apache score below 20
• Patients needed EN
• Post plastic surgery, including oral cancer or hypo-pharyngeal cancer

Exclusion criteria

• Coagulopathy,
• prolong prothrombin time (PPT) activated partial thromboplastin time (aPTT) more then 4 times
• Thrombocytopenia - low platelet count
• Clinically unstable: receiving two inotropic agents or Fraction of inspired Oxygen (FiO2) >70%
• Estimated ICU stay - less than 3 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Treatment group: specific acupuncture group(Acu)

Experimental group

Description:

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. Acupuncture doctor will disinfect the acupoints with alcohol and will perform acupuncture on the marked points with needle Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor.

Treatment:

Other: Specific acupuncture group

Drug: Metoclopramide 10mg

Control group: non-specific acupuncture group (Con-Acu)

Placebo Comparator group

Description:

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 pathologies, and are not reported to improve digestive function. Acupuncture doctor 1 will disinfect the marked acupoints with alcohol and will perform acupuncture on the marked points. Needle retention time will be 30 minutes. The needles will be withdrawn by acupuncture doctor

Treatment:

Other: Non-specific acupuncture group

Drug: Metoclopramide 10mg