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

NCT03934294 | Completed

• 1 other identifier: CMUH108-REC2-037(AR-1)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Hypopharyngeal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Amount of prokinetic drugs prescribed

  Up to 1 month

• The need of naso-jejunal feeding tube

  Up to 1 month

• The need of parental nutrition

  up to 1 month

• Incidents of vomits

  Up to 1 month

• Albumin blood levels

  Up to 1 month

Study Arms (2)

Treatment group: specific acupuncture group(Acu)

EXPERIMENTAL

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; Drug: Metoclopramide 10mg

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

PLACEBO COMPARATOR

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; Other: Non-specific acupuncture group

Interventions

Specific acupuncture group OTHER

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.

Also known as: Specific acupuncture to treat indigestion

Treatment group: specific acupuncture group(Acu)

Metoclopramide 10mg DRUG

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.

Also known as: Metoclopramide 10mg/ per 8 hours in the case of poor digestion

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

Non-specific acupuncture group OTHER

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.

Also known as: Non specific acupuncture to treat indigestion

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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

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

Taichung, Taichung, 40402, Taiwan

Location

MeSH Terms

Conditions

Mouth Neoplasms; Hypopharyngeal Neoplasms; Critical Illness

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Pei-Yu Kao, M.D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two groups, randomized, pre-post intervention study

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 1, 2019
• Study Start: May 15, 2019
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)