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

Fujian Provincial Cancer Hospital

Status: Completed

Conditions: Tumor Immunity; Carbohydrate; Cervical Cancer; Anesthesia

Treatments: Other: oral carbohydrate liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT03872635

FJCAAN01

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CHO Drinking Grope

Experimental group

Description:

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

Treatment:

Other: oral carbohydrate liquid

Traditional fast Grope

No Intervention group

Description:

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