Nutrition and Lifestyle Study Cohort of Colorectal Cancer in China

Colorectal Cancer Clinical Trial

Official title:

Impact of Nutrition, Dietary Pattern, Obesity, Physical Activity, Depression, Diabetes, Aspirin Use and Vitamin Supplement in Colorectal Cancer in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02215642
• Other study ID #: cdk-201001
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2014
• Last updated: February 18, 2018
• Start date: January 2009

Study information

• Verified date: February 2018
• Source: State Key Laboratory of Cancer Biology
• Contact: Dake Chu, M.D.
• Email: chudake[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Dake Chu	Xi'an	Shaanxi

Sponsors (12)

Lead Sponsor	Collaborator
State Key Laboratory of Cancer Biology	Beihua University, Beijing Cancer Hospital, Chengdu Medical College, China-Japan Friendship Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Second Military Medical University, Shanghai Jiao Tong University School of Medicine, Tang-Du Hospital, Third Military Medical University, Tianjin Union Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease-free survival	Disease-free survival is defined as the time elapsed from surgery to the first occurrence of any of the following events: recurrence of colorectal cancer; colorectal cancer distant metastasis; development of second non-colorectal malignancy excluding basal cell carcinomas of the skin and carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.	7 years
Primary	Disease-specific survival	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.	7 years
Secondary	Overall survival	Overall survival is defined as the time elapsed from surgery to the date of death from any cause.	7 years