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CompletedNCT03872635Updated Mar 13, 2019

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

An interventional study of oral carbohydrate liquid in Anesthesia, Cervical Cancer and Carbohydrate, sponsored by Fujian Cancer Hospital. Completed at 2 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Fujian Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2018, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Anesthesia
  • Cervical Cancer
  • Carbohydrate
  • Tumor Immunity
03

In context

Uterine Cervical Neoplasms

1,883 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 1,378 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    CHO Drinking Grope

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

    Other: oral carbohydrate liquid

  • No intervention
    Traditional fast Grope

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

Interventions

  • Otheroral 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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

2 sites
  • Fuqing Zhang
    Fuzhou, Fujian 350014, China
  • Mengxia Yao
    Fuzhou, Fujian 350014, China
08

References and documents

Publications

  • 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. PubMed 32309426 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03872635
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
Mar 13, 2019
Start date
Jan 1, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Mar 13, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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