NCT03872635

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

February 23, 2019

Last Update Submit

March 10, 2019

Conditions

AnesthesiaCervical CancerCarbohydrateTumor Immunity

Outcome Measures

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

    in 24 hrs

Secondary Outcomes (1)

  • tumor immunity

    in 24 hrs

Study Arms (2)

CHO Drinking Grope

EXPERIMENTAL

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

Other: oral carbohydrate liquid

Traditional fast Grope

NO INTERVENTION

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

Interventions

oral carbohydrate liquidOTHER

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 Drinking Grope

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fuqing Zhang

Fuzhou, Fujian, 350014, China

Location

Mengxia Yao

Fuzhou, Fujian, 350014, China

Location

Related Publications (1)

  • 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.

    PMID: 32309426DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2019

First Posted

March 13, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 13, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)