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Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period

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ClinicalTrials.gov Identifier: NCT03872635
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

Brief Summary:
To evaluate the effects of preoperative oral carbohydrate on postoperative insulin resistance and tumor immunity in cervical cancer patients with neoadjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Anesthesia Cervical Cancer Carbohydrate Tumor Immunity Other: oral carbohydrate liquid Not Applicable

Detailed Description:
Fifty-one patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery(CHO group) or to fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid)(FAST group).According to inclusion and exclusion standards, twenty-six patients undergoing the same surgery and standard fasting were selected as control group. Baseline and postoperative measurements of insulin sensitivity were assessed in term of fasting plasma glucose(FPG),fastingainsulin(FINS),HOMA-insulinaresistance(HOMA-IR),HOMA-insulin secretion function index(HOMA-IX) , HOMA-beta cell function index(HOMA-β),serum C-peptide and glucagon.Baseline and postoperative measurements of tumor immunity were evaluated using NK cell and T-cell dynamics.VAS score was introduced to assess preoperative comfort.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Drug or Drink Intervention and Temperature Protectionon for Cervical Cancer Patients on Insulin Resistance and Tumor Immunity
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: CHO Drinking Grope
receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery
Other: oral carbohydrate liquid
patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery

No Intervention: Traditional fast Grope
fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid



Primary Outcome Measures :
  1. insulin resistance [ Time Frame: in 24 hrs ]
    The patient's insulin resistance was determined by fasting plasma glucose(FPG),fastingainsulin(FINS), andHOMA-IR=FPG(mmol/L)×FINS(mIU/L)/22.5


Secondary Outcome Measures :
  1. tumor immunity [ Time Frame: in 24 hrs ]
    The patient's tumor immune level was determined by changes in T cells (CD3+、CD4+、CD8+、CD44+) and NK cells in the patient's blood



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patients aged from 18 to 60 years old were ASA level I to II, and the informed consent was signed by the patients, which was approved by the ethics committee of the hospital.
  2. Cervical squamous cell carcinoma was confirmed by cervical biopsy before pathologic surgery. CT showed no distant metastasis. All patients underwent total hysterectomy, bilateral adnexectomy and pelvic lymph node dissection.
  3. Fasting blood glucose was normal without diabetes, impaired glucose tolerance or other metabolic diseases.
  4. no gastric emptying dysfunction.

Exclusion Criteria:

  1. Dabetes
  2. Patients with obstruction of gastric emptying, such as pyloric obstruction, gastroesophageal reflux, nausea and vomiting, etc
  3. Obese (BMI >32) or severely malnourished (BMI<18.5)
  4. Distant metastasis, multiple primary cancers and recurrent tumors
  5. Patients with functional disorders of respiratory system, circulatory system, immune system, nervous system, urinary system and other organs
  6. Received blood transfusion and nutritional support within 2 weeks before surgery
  7. The supplement contains the sugar solution, the blood transfusion, the application glucocorticoid, the sympathetic blood vessel activity medicine in the operation.

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): NCT03872635


Locations
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China, Fujian
Fuqing Zhang
Fuzhou, Fujian, China, 350014
Mengxia Yao
Fuzhou, Fujian, China, 350014
Sponsors and Collaborators
Fujian Cancer Hospital

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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT03872635     History of Changes
Other Study ID Numbers: FJCAAN01
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 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
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Insulin Resistance
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs