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

Primary Purpose

Anesthesia, Cervical Cancer, Carbohydrate

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
oral carbohydrate liquid
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuqing Zhang
  • Mengxia Yao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CHO Drinking Grope

Traditional fast Grope

Arm Description

receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery

fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid

Outcomes

Primary Outcome Measures

insulin resistance
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

tumor immunity
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

Full Information

First Posted
February 23, 2019
Last Updated
March 10, 2019
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03872635
Brief Title
Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period
Official Title
Effects of Drug or Drink Intervention and Temperature Protectionon for Cervical Cancer Patients on Insulin Resistance and Tumor Immunity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Cervical Cancer, Carbohydrate, Tumor Immunity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHO Drinking Grope
Arm Type
Experimental
Arm Description
receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery
Arm Title
Traditional fast Grope
Arm Type
No Intervention
Arm Description
fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid
Intervention Type
Other
Intervention Name(s)
oral carbohydrate liquid
Intervention Description
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
Primary Outcome Measure Information:
Title
insulin resistance
Description
The patient's insulin resistance was determined by fasting plasma glucose(FPG),fastingainsulin(FINS), andHOMA-IR=FPG（mmol/L）×FINS（mIU/L）/22.5
Time Frame
in 24 hrs
Secondary Outcome Measure Information:
Title
tumor immunity
Description
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
Time Frame
in 24 hrs

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Fasting blood glucose was normal without diabetes, impaired glucose tolerance or other metabolic diseases. no gastric emptying dysfunction. Exclusion Criteria: Dabetes Patients with obstruction of gastric emptying, such as pyloric obstruction, gastroesophageal reflux, nausea and vomiting, etc Obese (BMI >32) or severely malnourished (BMI<18.5) Distant metastasis, multiple primary cancers and recurrent tumors Patients with functional disorders of respiratory system, circulatory system, immune system, nervous system, urinary system and other organs Received blood transfusion and nutritional support within 2 weeks before surgery The supplement contains the sugar solution, the blood transfusion, the application glucocorticoid, the sympathetic blood vessel activity medicine in the operation.
Facility Information:
Facility Name
Fuqing Zhang
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Mengxia Yao
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32309426
Citation
Zhang F, Yao M, Lin Z, Chen Y, Jiang H, Zeng M, Chen W. The Effects of Preoperative Oral Carbohydrate on Frequency of T and NK Cells in Patients with Cervical Cancer Treated Using Neoadjuvant Chemotherapy and Surgery: A Prospective Cohort Study. Biomed Res Int. 2020 Mar 16;2020:2101480. doi: 10.1155/2020/2101480. eCollection 2020.
Results Reference
derived

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

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