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

Not Applicable

Completed

• Conditions: Anesthesia; Tumor Immunity; Cervical Cancer; Carbohydrate
• Interventions: Other: oral carbohydrate liquid

• Registration Number: NCT03872635
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-23
• Study First Submitted QC: 2019-03-10
• Last Update Submitted: 2019-03-10
• Study First Posted: 2019-03-13
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHO Drinking Grope	oral carbohydrate liquid	receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery

Primary Outcome Measures

Name	Time	Method
insulin resistance	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

Name	Time	Method
tumor immunity	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

Trial Locations

Locations (2)

Fuqing Zhang; 🇨🇳 Fuzhou, Fujian, China

Mengxia Yao; 🇨🇳 Fuzhou, Fujian, China