Clinical trial NCT03934294: Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Hypopharyngeal Cancer
Keywords: Critically ill
Intensive care
Oral cancer
Hypo-pharyngeal cancer
Acupuncture
Digestion
ICU
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups, randomized, pre-post intervention study
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Time to reach Total Energy Expenditure
timeFrame: Up to 1 month
Secondary outcomes:
measure: Amount of prokinetic drugs prescribed
timeFrame: Up to 1 month
measure: The need of naso-jejunal feeding tube
timeFrame: Up to 1 month
measure: The need of parental nutrition
timeFrame: up to 1 month
measure: Incidents of vomits
timeFrame: Up to 1 month
measure: Albumin blood levels
timeFrame: Up to 1 month
measure: Total ICU stay
timeFrame: Up to 23 month
measure: Total hospital stay
timeFrame: Up to 23 month
measure: Total mechanical ventilation in days
timeFrame: Up to 23 month
measure: Total mortality
timeFrame: Up to 23 month
measure: Incidents of diarrhea
timeFrame: Up to 1 month
measure: Incidents of constipation
timeFrame: Up to 1 month
measure: Incidents of nausea
timeFrame: Up to 1 month
measure: Incidents of gastrointestinal bleeding
timeFrame: Up to 1 month
measure: Incidents of fever episodes
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: surgical and burn intensive care departments and the plastic surgical department of China Medical University Hospital in Taichung city, Taiwan.
state: Taichung
Study officials:
affiliation: China Medical University Hospital
name: Pei-Yu Kao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: