Change in Body Weight During Treatment of Advanced Colorectal Cancer

NCT ID: NCT04232748

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-03-01

Brief Summary

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Colorectal cancer (CRC) is a significant and growing health burden in Hong Kong. According to data from Hong Kong Cancer Registry, CRC ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. The investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic CRC.

Detailed Description

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Studies have suggested that exposure to a greater number of chemotherapeutic agents is associated with better survival in metastatic colorectal cancer.

Multiple factors might affect body weight during treatment. Cancer-related symptoms can impair quality of life and appetite. Cachexia syndrome affects around 50% of colon cancer patients and is characterized by cancer-induced catabolism with involuntary weight loss (fat and muscle), patients have increased lipolysis and change in skeletal muscle metabolism, including increased energy expenditure at rest and protein degradation, and decreased protein synthesis. Besides these disease factors, treatment related side effects are common causes of weight loss, such as inability to ingest or digest food effectively due to nausea, vomiting, and malaise. Based on these factors and the hypotheses between tumour control and weight gain, monitoring the serial weight change can have practical value.

Conditions

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Cancer, Colorectal Chemotherapy Effect Weight Loss Prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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stage IV colorectal cancer

stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes

first line systemic treatment for colorectal cancer

Intervention Type DRUG

systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.

Interventions

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first line systemic treatment for colorectal cancer

systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically proven adenocarcinoma of colorectal origin
* Stage IV disease with systemic treatment
* Estimated life expectancy \>3 months
* Adequate organ functions

Exclusion Criteria

* Eastern Cooperative Oncology Group performance status 3 or above
* Pregnancy
* Human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS)
* Past medical history of another cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tuen Mun Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shing Fung Lee

Resident Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shing Fung Lee, MBBS, M Sc

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong

Locations

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Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Shing Fung Lee, MBBS, M Sc

Role: CONTACT

85224685087

King Fung Tsang, M Sc

Role: CONTACT

85224685769

Facility Contacts

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Shing Fung Lee, MBBS, M Sc

Role: primary

852 2468 5087

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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NTWC/CREC/18027

Identifier Type: -

Identifier Source: org_study_id

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