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

NCT ID: NCT03872635

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-31

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.

Conditions

Anesthesia; Cervical Cancer; Carbohydrate; Tumor Immunity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHO Drinking Grope

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

Group Type: EXPERIMENTAL

oral carbohydrate liquid

Intervention Type: OTHER

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

Traditional fast Grope

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuqing Zhang

Fuzhou, Fujian, China

Mengxia Yao

Fuzhou, Fujian, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32309426 (View on PubMed)

Other Identifiers

FJCAAN01

Identifier Type: -

Identifier Source: org_study_id