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NCT Number: NCT03872635

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fuqing Zhang, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • Fasting blood glucose was normal without diabetes, impaired glucose tolerance or other metabolic diseases.
  • no gastric emptying dysfunction.

Exclusion criteria

  • Dabetes
  • Patients with obstruction of gastric emptying, such as pyloric obstruction, gastroesophageal reflux, nausea and vomiting, etc
  • Obese (BMI >32) or severely malnourished (BMI<18.5)
  • Distant metastasis, multiple primary cancers and recurrent tumors
  • Patients with functional disorders of respiratory system, circulatory system, immune system, nervous system, urinary system and other organs
  • Received blood transfusion and nutritional support within 2 weeks before surgery
  • The supplement contains the sugar solution, the blood transfusion, the application glucocorticoid, the sympathetic blood vessel activity medicine in the operation.

Treatment and study plan

oral carbohydrate liquid

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

Primary outcomes

  1. insulin resistance

    Time frame: 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 outcomes

  1. tumor immunity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2019
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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