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

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ClinicalTrials.gov Identifier: NCT03934294
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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 treatment 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, devolved feeding intolerance more than 2 time in the first postoperative day, 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 treating 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 treatment 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, devolved feeding intolerance more than 2 time in the first postoperative day, 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 treating 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


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Study Type : Interventional  (Clinical Trial)
Estimated 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 1. Acupuncture doctor 1 (blind) will mark the acupoints on the patients' body with a green sticker and leave the room, then acupuncture doctor 2 (blind) will enter the room and preform acupuncture on the marked points. 30 minutes after needle insertion, acupuncture doctor 2 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
Estimated Study Start Date : May 12, 2019
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : June 1, 2021


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 1 (blind) will mark the points on the patients' body with a green sticker and leave the room. Acupuncture doctor 2 (blind) will disinfect the marked 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 2

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 (blind) will mark the points on the patients' body with a green sticker and leave the room. Acupuncture doctor 2 (blind) will disinfect the marked 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 2

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




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



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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
  • Patients who devolved feeding intolerance more than 2 time in the first postoperative day.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934294


Contacts
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Contact: Yu-Chen Lee, M.D.,PhD 886-975-682023 d5167@mail.cmuh.org.tw

Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Yu-Chen Lee, M.D.,PhD China Medical University Hospital

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03934294     History of Changes
Other Study ID Numbers: CMUH108-REC2-037
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Critical Illness
Mouth Neoplasms
Hypopharyngeal Neoplasms
Pharyngeal Neoplasms
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