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Adherence to the Antiemesis National Comprehensive Cancer Network (NCCN) Guideline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740672
Recruitment Status : Unknown
Verified November 2018 by Lei Li, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : November 14, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Study Description
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Brief Summary:
This study aims to investigate the adherence to the antiemesis NCCN guideline in Chinese patients of gynecologic malignancies, who are given chemotherapy treatment. The risk of chemotherapy induced nausea and vomiting (CINV) is calculated by the questionnaire supported by the website "CINV Risk Assessment" (http://www.riskcinv.org/).

Condition or disease
Gynecologic Cancer Chemotherapy-induced Nausea and Vomiting

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to the Antiemesis National Comprehensive Cancer Network (NCCN) Guideline in Chinese Patients of Gynecologic Malignancies
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. risk of chemotherapy induced nausea and vomiting [ Time Frame: One year ]
    The risk of chemotherapy induced nausea and vomiting is calculated by the questionnaire supported by the website "CINV Risk Assessment" (http://www.riskcinv.org/). The difference of patients adhered to and not to NCCN guideline is compared.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
All patients who are given chemotherapy treatment for gynecologic malignancies are included.
Criteria

Inclusion Criteria:

  • Good performance status
  • Aged 18 years or older
  • Signed an approved informed consents

Exclusion Criteria:

  • Not meeting all of the inclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740672


Contacts
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Contact: Lei Li, M.D. 8613911988831 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03740672    
Other Study ID Numbers: GO-CINV
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive