Change in Body Weight During Treatment of Advanced Colorectal Cancer

Sponsor

Tuen Mun Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04232748

Collaborator

(none)

264

Enrollment

Location

37.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Colorectal Chemotherapy Effect Weight Loss Prognosis	Drug: first line systemic treatment for colorectal cancer

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

264 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
stage IV colorectal cancer 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 systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.

Arm

Intervention/Treatment

stage IV colorectal cancer

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

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

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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