Change in Body Weight During Treatment of Advanced Colorectal Cancer

Study Overview
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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.

Official Title
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Clinical Significance of Change in Body Weight During Treatment of Advanced Colorectal Cancer Patients - A Pilot Study

Conditions
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Cancer, Colorectal, Chemotherapy Effect, Weight Loss, Prognosis

Intervention / Treatment
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* Drug: first line systemic treatment for colorectal cancer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stage IV colorectal cancer<br>stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes | Drug: first line systemic treatment for colorectal cancer<br>* systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Survival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up | From date of start of anti-cancer treatment until the date of first documented progression (assessed by physical examination, imaging, or blood biomarkers) or date of death from any cause, whichever came first, assessed up to 60 months | 
| Overall survival | Survival time from start of anti-cancer treatment until death from any cause, or loss of follow-up | From date of start of anti-cancer treatment until the date of death from any cause (assessed by physical examination, imaging, or blood biomarkers), assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy dose change | Chemotherapy dose change (in percentage change) | from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months | 
| Chemotherapy interruption | Chemotherapy dose interruption (in percentage change) | from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, survival, chemotherapy, weight