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

Oral Cancer Clinical Trial

Official title:

Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients: A Protocol for Double Blind Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934294
• Other study ID #: CMUH108-REC2-037(AR-1)
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Pharyngeal Neoplasms

Intervention

Other:
• Specific acupuncture group
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.

Drug:
• Metoclopramide 10mg
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.

Other:
• Non-specific acupuncture group
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.

Locations

Country	Name	City	State
Taiwan	surgical and burn intensive care departments and the plastic surgical department of China Medical University Hospital in Taichung city, Taiwan.	Taichung City	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach Total Energy Expenditure	Number of days in takes for each patient to achieve the Total Energy Expenditure	Up to 1 month
Secondary	Amount of prokinetic drugs prescribed	Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage	Up to 1 month
Secondary	The need of naso-jejunal feeding tube	After 5 days of conservative treatment for the poor digestion (naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day)	Up to 1 month
Secondary	The need of parental nutrition	In patients who cannot digest with daily naso-gastric tube drainage of more than 500ml per day or severe diarrhea of more than 1000 ml per day	up to 1 month
Secondary	Incidents of vomits	Incidents of vomits in total number of times and volume in micro liters	Up to 1 month
Secondary	Albumin blood levels	Patient's Albumin blood levels will help to assets patient's nutrition status	Up to 1 month
Secondary	Total ICU stay	Total ICU stay in days	Up to 23 month
Secondary	Total hospital stay	Total hospital stay in days	Up to 23 month
Secondary	Total mechanical ventilation in days	A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day	Up to 23 month
Secondary	Total mortality	In case of mortality ,total mortality will be compered between the two groups	Up to 23 month
Secondary	Incidents of diarrhea	Incidents of diarrhea in number of times and volume in micro liters	Up to 1 month
Secondary	Incidents of constipation	No stool passage in 3 days will be considered as constipation	Up to 1 month
Secondary	Incidents of nausea	Incidents of nausea in number of times , measured by patient complains	Up to 1 month
Secondary	Incidents of gastrointestinal bleeding	Positive occult blood test of the naso-gastric tube drainage and in the stool	Up to 1 month
Secondary	Incidents of fever episodes	Body temperature more than 38 degrees Celsius	Up to 1 month