Cancer, ColorectalNCT04232748
Change in Body Weight During Treatment of Advanced Colorectal Cancer
An observational study of Cancer, Colorectal and Chemotherapy Effect, run by Tuen Mun Hospital at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Colorectal, Chemotherapy Effect, Weight Loss
- What is being tested?
- first line systemic treatment for colorectal cancer
- Type of treatment
- Injection or infusion
- How many people
- 264 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single institutional cohort of stage IV (advanced) colorectal cancer patients who undergo systemic treatments.
Who may be able to join
- Histologically proven adenocarcinoma of colorectal origin
- Stage IV disease with systemic treatment
- Estimated life expectancy >3 months
- Adequate organ functions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun
Hong Kong
Shing Fung Lee, MBBS, M Sc, 852 2468 5087, leesfm@ha.org.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Colorectal, Chemotherapy Effect, Weight Loss, Prognosis
- Being tested
- first line systemic treatment for colorectal cancer
- Keywords
- cancer, survival, chemotherapy, weight
- Medical subject headings
- Colorectal Neoplasms, Weight Loss, Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first line systemic treatment for colorectal cancerDrug
systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.
| Study group | Role | What they receive |
|---|---|---|
| stage IV colorectal cancer | stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes Receives: Drug: first line systemic treatment for colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Survival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up
Measured: 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
Survival time from start of anti-cancer treatment until death from any cause, or loss of follow-up
Measured: 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 (2)
Chemotherapy dose change
Chemotherapy dose change (in percentage change)
Measured: from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
Chemotherapy interruption
Chemotherapy dose interruption (in percentage change)
Measured: from start of first-line anti-cancer treatment until completion, assessed by clinical assessment up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shing Fung Lee, Tuen Mun Hospital
- Investigators
- Shing Fung Lee, MBBS, M Sc, Principal investigator, Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232748
- Sponsor's protocol ID
- NTWC/CREC/18027
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Change in Body Weight During Treatment of Advanced Colorectal Cancer Patients - A Pilot Study
- ClinicalTrials.gov ID
- NCT04232748
- Acronym / sponsor ID
- NTWC/CREC/18027
- Conditions
- Cancer, Colorectal, Chemotherapy Effect, Weight Loss, Prognosis
- Keywords
- cancer, survival, chemotherapy, weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stage IV colorectal cancer | – | Drug: first line systemic treatment for colorectal cancerstage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single institutional cohort of stage IV (advanced) colorectal cancer patients who undergo systemic treatments.
Key inclusion criteria (4 listed)
- Histologically proven adenocarcinoma of colorectal origin
- Stage IV disease with systemic treatment
- Estimated life expectancy >3 months
- Adequate organ functions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| first line systemic treatment for colorectal cancersystemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab. | Drug | stage IV colorectal cancer |
Primary outcome
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
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
2 secondary outcomes
Chemotherapy dose change
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shing Fung Lee, MBBS, M Sc principal investigator
Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Colorectal and Chemotherapy Effect, run by Tuen Mun Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shing Fung Lee, MBBS, M Sc (85224685087, leesfm@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.