Change in Body Weight During Treatment of Advanced Colorectal Cancer
- Conditions
- PrognosisCancer, ColorectalChemotherapy EffectWeight Loss
- Interventions
- Drug: first line systemic treatment for colorectal cancer
- Registration Number
- NCT04232748
- Lead Sponsor
- Tuen Mun Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 264
- Histologically proven adenocarcinoma of colorectal origin
- Stage IV disease with systemic treatment
- Estimated life expectancy >3 months
- Adequate organ functions
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description stage IV colorectal cancer first line systemic treatment for colorectal cancer stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes
- Primary Outcome Measures
Name Time Method Overall survival 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 Survival time from start of anti-cancer treatment until death from any cause, or loss of follow-up
Progression-free survival 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 Survival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up
- Secondary Outcome Measures
Name Time Method Chemotherapy interruption from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months Chemotherapy dose interruption (in percentage change)
Chemotherapy dose change from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months Chemotherapy dose change (in percentage change)
Trial Locations
- Locations (1)
Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun
ðŸ‡ðŸ‡°Hong Kong, Hong Kong