Oral Cancer, Hypopharyngeal Cancer
Conditions
Keywords
Critically ill, Intensive care, Oral cancer, Hypo-pharyngeal cancer, Acupuncture, Digestion, ICU
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
Interventions
OTHERSpecific 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.
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.
OTHERNon-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.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
two groups, randomized, pre-post intervention study
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach Total Energy Expenditure | Up to 1 month | Number of days in takes for each patient to achieve the Total Energy Expenditure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidents of diarrhea | Up to 1 month | Incidents of diarrhea in number of times and volume in micro liters |
| Incidents of constipation | Up to 1 month | No stool passage in 3 days will be considered as constipation |
| Incidents of nausea | Up to 1 month | Incidents of nausea in number of times , measured by patient complains |
| The need of parental nutrition | 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 |
| Incidents of vomits | Up to 1 month | Incidents of vomits in total number of times and volume in micro liters |
| Albumin blood levels | Up to 1 month | Patient's Albumin blood levels will help to assets patient's nutrition status |
| Total mortality | Up to 23 month | In case of mortality ,total mortality will be compered between the two groups |
| Total hospital stay | Up to 23 month | Total hospital stay in days |
| Total mechanical ventilation in days | Up to 23 month | A day of mechanical ventilation is at least 6 hours of mechanical ventilation in one day |
| Amount of prokinetic drugs prescribed | Up to 1 month | Secondary outcomes measures are the amount of prokinetic drugs prescribed by the ICU doctor in total dosage |
| The need of naso-jejunal feeding tube | 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) |
| Incidents of gastrointestinal bleeding | Up to 1 month | Positive occult blood test of the naso-gastric tube drainage and in the stool |
| Incidents of fever episodes | Up to 1 month | Body temperature more than 38 degrees Celsius |
| Total ICU stay | Up to 23 month | Total ICU stay in days |
Countries
Taiwan
Outcome results
None listed