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

Anesthesia Clinical Trial

Official title:

Effects of Drug or Drink Intervention and Temperature Protectionon for Cervical Cancer Patients on Insulin Resistance and Tumor Immunity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872635
• Other study ID #: FJCAAN01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Carbohydrate
• Cervical Cancer
• Insulin Resistance
• Tumor Immunity
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fuqing Zhang	Fuzhou	Fujian
China	Mengxia Yao	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	in 24 hrs
Secondary	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	in 24 hrs