Palliative CareNCT01399294
Cross Sectional Study of Constipation in Advanced Cancer Patients
An observational study of Palliative Care and Constipation, run by Yan Chai Hospital at 2 sites in China.
Trial summary
Constipation is a common problem in palliative cancer patients. However, there were insufficient randomized controlled trial (RCT) data to identify the "best" laxative or combination of laxatives in these patients. Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Constipation, Traditional Chinese Medicine
- How many people
- 255 participants
- Where
- 2 sitesChina
- Study dates
- May 2010to Feb 2011
- 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: Advanced cancer patients (aged 18 or above) under the care of palliative care units who are on laxatives and who have constipation during recruitment.
Who may be able to join
- advanced cancer patients
- on medication for facilitating bowel movement and/or constipation visual analogue scale >=2
Who cannot join
- unable to communicate
- cognitive impaired
- put on colostomy bag
- clinically diagnosed gastrointestinal obstruction
- at end-of-life
Trial locations and contacts
2 sites in 1 country.
China2 sites
Caritas Medical Centre
Hong Kong, Hong Kong
Our Lady of Maryknoll Hospital
Hong Kong, Hong Kong
About this study
Official title: Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation
Constipation is a common problem in palliative cancer patients. However, there were insufficient randomized controlled trial (RCT) data to identify the "best" laxative or combination of laxatives in these patients.
Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients. More than half had received at least one form of TCM therapy according to the survey carried in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging effects simultaneously may be more preferred to relieve constipation by local palliative cancer patients.
Read more
TCM syndrome differentiated by collecting all symptoms and signs through the classic four diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.
The present study is the first local study to evaluate the bowel habits and TCM syndrome of advanced cancer patients with constipation. We hope that the results not only can shed light on patient's own reporting or experience of constipation and the effectiveness of current practice, but also can draw up a CHM formulation for advanced cancer patients with constipation.
- Conditions
- Palliative Care, Constipation, Traditional Chinese Medicine
- Keywords
- Palliative Care, Advanced Cancer, Constipation, Traditional Chinese Medicine, Syndrome Distribution
- Medical subject headings
- Constipation
What is being measured
The primary outcome is the main question the study is designed to answer.
TCM syndrome distribution
Five TCM syndromes, i.e. Excess Heat, Qi Stagnation, Qi Deficiency, Yang Deficiency and Yin Deficiency, are differentiated by TCM practitioner.
Measured: End of recruitment (estimated timeframe: 3 months)
Secondary outcomes (1)
bowel habit
- Patient's own reporting or experience of constipation
- Effectiveness of current practice in relief of constipation
Measured: End of recruitment (estimated timeframe: 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yan Chai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Hong Kong Baptist University
- Investigators
- Doris MW Tse, MD, Principal investigator, Department of Medicine & Geriatrics / ICU, Caritas Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399294
- Sponsor's protocol ID
- Constipation/TCM2010
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation
- ClinicalTrials.gov ID
- NCT01399294
- Acronym / sponsor ID
- Constipation/TCM2010
- Conditions
- Palliative Care, Constipation, Traditional Chinese Medicine
- Keywords
- Palliative Care, Advanced Cancer, Constipation, Traditional Chinese Medicine, Syndrome Distribution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Yan Chai HospitalUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Hong Kong Baptist University
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jul 2011 (estimated)
- 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.
Constipation is a common problem in palliative cancer patients. However, there were insufficient randomized controlled trial (RCT) data to identify the "best" laxative or combination of laxatives in these patients.
Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients. More than half had received at least one form of TCM therapy according to the survey carried in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging effects simultaneously may be more preferred to relieve constipation by local palliative cancer patients.
TCM syndrome differentiated by collecting all symptoms and signs through the classic four diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.
The present study is the first local study to evaluate the bowel habits and TCM syndrome of advanced cancer patients with constipation. We hope that the results not only can shed light on patient's own reporting or experience of constipation and the effectiveness of current practice, but also can draw up a CHM formulation for advanced cancer patients with constipation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced cancer patients (aged 18 or above) under the care of palliative care units who are on laxatives and who have constipation during recruitment.
Key inclusion criteria (2 listed)
- advanced cancer patients
- on medication for facilitating bowel movement and/or constipation visual analogue scale >=2
Key exclusion criteria (5 listed)
- unable to communicate
- cognitive impaired
- put on colostomy bag
- clinically diagnosed gastrointestinal obstruction
- at end-of-life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TCM syndrome distribution
Time frame: End of recruitment (estimated timeframe: 3 months)
Five TCM syndromes, i.e. Excess Heat, Qi Stagnation, Qi Deficiency, Yang Deficiency and Yin Deficiency, are differentiated by TCM practitioner.
1 secondary outcome
bowel habit
Time frame: End of recruitment (estimated timeframe: 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Doris MW Tse, MD principal investigator
Department of Medicine & Geriatrics / ICU, Caritas Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Constipation, run by Yan Chai Hospital at 2 sites in China.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM syndrome distribution (time frame: End of recruitment (estimated timeframe: 3 months)). 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 21 Jul 2011.