Clinical trial NCT04232748: Change in Body Weight During Treatment of Advanced Colorectal Cancer
Official title: Clinical Significance of Change in Body Weight During Treatment of Advanced Colorectal Cancer Patients - A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer, Colorectal
Chemotherapy Effect
Weight Loss
Prognosis
Keywords: cancer
survival
chemotherapy
weight
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-18
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single institutional cohort of stage IV (advanced) colorectal cancer patients who undergo systemic treatments.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 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
measure: Overall survival
timeFrame: 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 outcomes:
measure: Chemotherapy dose change
timeFrame: from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
measure: Chemotherapy interruption
timeFrame: from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun
Study officials:
affiliation: Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong
name: Shing Fung Lee, MBBS, M Sc
role: PRINCIPAL_INVESTIGATOR
References: