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

NCT03872635CompletedNAINTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

Fujian Cancer Hospital

Enrollment

Start Date

2018-01-01

Completion Date

2018-12-31

Study Type

INTERVENTIONAL

Official Title

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

Interventions

oral carbohydrate liquid

Conditions

AnesthesiaCervical CancerCarbohydrateTumor Immunity

Eligibility

Age Range

18 Years – 70 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: in 24 hrs

Secondary Outcomes

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

Time frame: in 24 hrs

Locations

Fuqing Zhang, Fuzhou, China

Mengxia Yao, Fuzhou, China

Linked Papers

2020-03-16

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

Background. Immune dysfunction can occur after neoadjuvant chemotherapy (NAC) and surgery for cancer. We investigated whether preoperative oral carbohydrate affected the postoperative percentages of T cells (CD4+ and CD8+) and natural killer (NK) cells in patients with cervical cancer treated with NAC and surgery. Methods. This prospective cohort study enrolled consecutive patients with cervical cancer treated by radical hysterectomy with PLND at the Gynecologic Oncology Department of Fujian Provincial Cancer Hospital (China) between January 2018 and December 2018. Patients were divided into three groups according to the treatment method: NAC (two cycles, surgery 1 month later), NAC+CHO (chemotherapy and surgical methods same as with the NAC group but with 300 mL of oral carbohydrate administered 2 h before surgery), and non‐NAC (surgery alone). Percentages of NK, CD3+, CD4+, and CD8+ cells were evaluated by flow cytometry the day after the first admission, just before surgery, immediately after tracheal tube removal, and the day after surgery. This trial is registered with NCT03872635 at clinicaltrials.com. Results. The final analysis included 77 patients (non‐NAC group, n = 26; NAC group, n = 25; and NAC‐CHO group, n = 26). Baseline characteristics and preoperative NK, CD3+, CD4+, and CD8+ cell percentages were similar between groups. Postoperatively, all groups exhibited reductions in NK, CD3+, and CD4+ cell percentages and increases in CD8+ cell percentages (all P < 0.05). The changes in NK, CD3+, CD4+, and CD8+ cell percentages were attenuated in the NAC‐CHO group (P < 0.05 vs. both other groups). Conclusion. Preoperative oral carbohydrate can improve the postoperative populations of NK and T cells after the treatment of cervical cancer by NAC and surgery.

Linked Investigators

Wenhua Chen