Change in Body Weight During Treatment of Advanced Colorectal Cancer

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232748
• Other study ID #: NTWC/CREC/18027
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2020
• Source: Tuen Mun Hospital
• Contact: Shing Fung Lee, MBBS, M Sc
• Phone: 85224685087
• Email: leesfm[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Cancer, Colorectal
• Chemotherapy Effect
• Colorectal Neoplasms
• Prognosis
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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