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Change in Body Weight During Treatment of Advanced Colorectal Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04232748
Enrollment
264
Registered
2020-01-18
Start date
2019-01-01
Completion date
2022-03-01
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Colorectal, Chemotherapy Effect, Prognosis, Weight Loss

Keywords

cancer, survival, chemotherapy, weight

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.

Interventions

DRUGfirst line systemic treatment for colorectal cancer

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

Sponsors

Tuen Mun Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survivalFrom 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 monthsSurvival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up
Overall survivalFrom 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 monthsSurvival time from start of anti-cancer treatment until death from any cause, or loss of follow-up

Secondary

MeasureTime frameDescription
Chemotherapy dose changefrom start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 monthsChemotherapy dose change (in percentage change)
Chemotherapy interruptionfrom start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 monthsChemotherapy dose interruption (in percentage change)

Countries

Hong Kong

Contacts

Primary ContactShing Fung Lee, MBBS, M Sc
leesfm@ha.org.hk85224685087
Backup ContactKing Fung Tsang, M Sc
tkf179@ha.org.hk85224685769

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026