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

• ClinicalTrials.gov Identifier: NCT03934294
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: March 24, 2021
• Sponsor: China Medical University Hospital
• Information provided by (Responsible Party): China Medical University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Oral Cancer; Hypopharyngeal Cancer	Other: Specific acupuncture group; Drug: Metoclopramide 10mg; Other: Non-specific acupuncture group	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: two groups, randomized, pre-post intervention study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Patients will be randomized to one of two groups: Acu/ Con in a 1:1 ratio. The random number and patient name will be written down on an non transparent envelope by a study nurse. The study nurse will provide an envelope containing a sheet depicting the acupoint name, location and picture (Acu / Con) to the acupuncture doctor. Acupuncture doctor (blind) will preform acupuncture on the points. 30 minutes after needle insertion, acupuncture doctor will withdraw the needles. Acupuncturists, ICU nurses, ICU doctors, researchers and statisticians will all be blind to group allocation and to the meaning of the random numbers until all acupuncture treatments have been completed.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 15, 2019
• Actual Primary Completion Date: March 19, 2021
• Actual Study Completion Date: March 19, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment group: specific acupuncture group(Acu); 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.	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.; Other Name: Specific acupuncture to treat indigestion; 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 Name: Metoclopramide 10mg/ per 8 hours in the case of poor digestion
Placebo Comparator: Control group: non-specific acupuncture group (Con-Acu); 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	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 Name: Metoclopramide 10mg/ per 8 hours in the case of poor digestion; 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.; Other Name: Non specific acupuncture to treat indigestion

Outcome Measures

Primary Outcome Measures :

1. Time to reach Total Energy Expenditure [ Time Frame: Up to 1 month ]
   Number of days in takes for each patient to achieve the Total Energy Expenditure

Secondary Outcome Measures :

1. Amount of prokinetic drugs prescribed [ Time Frame: Up to 1 month ]
   Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage
2. The need of naso-jejunal feeding tube [ Time Frame: Up to 1 month ]
   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)
3. The need of parental nutrition [ Time Frame: up to 1 month ]
   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
4. Incidents of vomits [ Time Frame: Up to 1 month ]
   Incidents of vomits in total number of times and volume in micro liters
5. Albumin blood levels [ Time Frame: Up to 1 month ]
   Patient's Albumin blood levels will help to assets patient's nutrition status
6. Total ICU stay [ Time Frame: Up to 23 month ]
   Total ICU stay in days
7. Total hospital stay [ Time Frame: Up to 23 month ]
   Total hospital stay in days
8. Total mechanical ventilation in days [ Time Frame: Up to 23 month ]
   A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day
9. Total mortality [ Time Frame: Up to 23 month ]
   In case of mortality ,total mortality will be compered between the two groups
10. Incidents of diarrhea [ Time Frame: Up to 1 month ]
    Incidents of diarrhea in number of times and volume in micro liters
11. Incidents of constipation [ Time Frame: Up to 1 month ]
    No stool passage in 3 days will be considered as constipation
12. Incidents of nausea [ Time Frame: Up to 1 month ]
    Incidents of nausea in number of times , measured by patient complains
13. Incidents of gastrointestinal bleeding [ Time Frame: Up to 1 month ]
    Positive occult blood test of the naso-gastric tube drainage and in the stool
14. Incidents of fever episodes [ Time Frame: Up to 1 month ]
    Body temperature more than 38 degrees Celsius

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Taiwan

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

Taichung City, Taichung, Taiwan, 40402

Sponsors and Collaborators

China Medical University Hospital

Investigators

• Principal Investigator: Pei-Yu Kao, M.D.; China Medical University Hospital

More Information

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT03934294
• Other Study ID Numbers: CMUH108-REC2-037(AR-1)
• First Posted: May 1, 2019
• Last Update Posted: March 24, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:

Critically ill; Intensive care; Oral cancer; Hypo-pharyngeal cancer; Acupuncture; Digestion; ICU

Additional relevant MeSH terms:

Mouth Neoplasms; Hypopharyngeal Neoplasms; Pharyngeal Neoplasms; Critical Illness; Disease Attributes; Pathologic Processes; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Metoclopramide; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action