Nutrition and Lifestyle Study Cohort of Colorectal Cancer in China

• Conditions: Colorectal Cancer

• Registration Number: NCT02215642
• Lead Sponsor: State Key Laboratory of Cancer Biology

Brief Summary

Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports concluded nutrition status and lifestyle factors were associated with colorectal cancer risk, however, the influence of nutrition and lifestyle factors on cancer outcome in colorectal cancer survivors is largely unknown.The investigators will explore the impact of nutrition status, life style, dietary pattern, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement on colorectal cancer outcome. The investigators will recruit approximately 50,000 patients as a prospective study cohort. During follow up, the investigators will explore the association of these factors with disease-specific survival, disease-free survival and overall survival of patients. The investigators believe that this project will facilitate the establishment of domestic nutrition and lifestyle data of colorectal cancer of China, and the improvement of the quality of clinical management of patients with colorectal cancer.

Detailed Description

Background - Colorectal cancer incidence is increasing at an alarming rate in China. Recent studies reported that nutrition status and lifestyle factors such as dietary pattern, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement were associated cancer risk. Yet, the influence of nutrition and lifestyle factors on colorectal cancer outcome (i.e. recurrence and survival) in colorectal cancer survivors is largely unknown. And there is currently no large cohort studies investigated the impact of these factors on colorectal cancer outcomes in China.

Objectives - Our study aims to evaluate the impact of nutrition status and lifestyle factors such as dietary pattern, tea consumption, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement on colorectal cancer outcome (disease-specific survival, disease-free survival and overall survival).

Settings and methods - The study will recruit approximately 50,000 participants with colorectal cancer from 12 public hospitals in China after informed consent. Appropriate questionnaires will be utilized to evaluate nutrition status and lifestyle factors such as dietary pattern, tea consumption, obesity, physical activity, depression, diabetes, aspirin use and vitamin supplement. The association of disease-specific survival, disease-free survival and overall survival with these factors will be evaluated.

Impact - To the best of our knowledge, this is the first large cohort, systematically investigation of the impact of nutrition status and lifestyle factors on colorectal cancer outcome. When complete, our investigation would supply a systematical and precise understanding of the impact nutrition status and lifestyle factors on cancer out come in China.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-18
• Last Update Posted: 2018-02-20
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• Patient must have a histologically proven adenocarcinoma of colon or rectum cancer.
• Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
• Patients must have recovered from any effects of surgery.
• Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
• Patients must provide a signed consent to participate in the study.
• Patients must complete all questionnaires.

Exclusion Criteria

• Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
• History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
• Unresolved bacterial infection requiring treatment with antibiotics.
• Pregnant or lactating women may not participate in the study.
• Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
• Gilbert's disease.
• Other serious concurrent infection
• Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-specific survival	7 years	Disease-specific survival is defined as the time elapsed from surgery to death due to CRC. Concretely, the cause of death obtained in the follow up was classified according to ICD-10 conventions. Disease-specific deaths included those with an underlying cause attributed to ICD-10 codes C18.0-C20.0 or C26.0.

Secondary Outcome Measures

Name	Time	Method
Overall survival	7 years	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.

Trial Locations

Locations (1)

Dake Chu; 🇨🇳 Xi'an, Shaanxi, China