Change in Body Weight During Treatment of Advanced Colorectal Cancer

January 16, 2020 updated by: Shing Fung Lee, Tuen Mun Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shing Fung Lee, MBBS, M Sc
  • Phone Number: 85224685087
  • Email: leesfm@ha.org.hk

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun
        • Contact:
          • Shing Fung Lee, MBBS, M Sc
          • Phone Number: 852 2468 5087
          • Email: leesfm@ha.org.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Single institutional cohort of stage IV (advanced) colorectal cancer patients who undergo systemic treatments.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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
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
Overall survival
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy dose change
Time Frame: from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
Chemotherapy dose change (in percentage change)
from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
Chemotherapy interruption
Time Frame: from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
Chemotherapy dose interruption (in percentage change)
from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Investigators

  • Principal Investigator: Shing Fung Lee, MBBS, M Sc, Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTWC/CREC/18027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Loss

Clinical Trials on first line systemic treatment for colorectal cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe