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Cross Sectional Study of Constipation in Advanced Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399294
First Posted: July 21, 2011
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hospital Authority, Hong Kong
Hong Kong Baptist University
Information provided by:
Yan Chai Hospital
  Purpose

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.


Condition
Palliative Care Constipation Traditional Chinese Medicine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation

Resource links provided by NLM:


Further study details as provided by Yan Chai Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • bowel habit [ Time Frame: End of recruitment (estimated timeframe: 3 months) ]
    1. Patient's own reporting or experience of constipation
    2. Effectiveness of current practice in relief of constipation


Enrollment: 255
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • advanced cancer patients
  • on medication for facilitating bowel movement and/or constipation visual analogue scale >=2

Exclusion Criteria:

  • unable to communicate
  • cognitive impaired
  • put on colostomy bag
  • clinically diagnosed gastrointestinal obstruction
  • at end-of-life
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399294


Locations
China, Hong Kong
Caritas Medical Centre
Hong Kong, Hong Kong, China
Our Lady of Maryknoll Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Yan Chai Hospital
Hospital Authority, Hong Kong
Hong Kong Baptist University
Investigators
Principal Investigator: Doris MW Tse, MD Department of Medicine & Geriatrics / ICU, Caritas Medical Centre
  More Information

Responsible Party: Dr. Tse Man Wah, Doris / Chief of Service, Department of Medicine & Geriatrics / ICU, Caritas Medical Centre
ClinicalTrials.gov Identifier: NCT01399294     History of Changes
Other Study ID Numbers: Constipation/TCM2010
First Submitted: July 18, 2011
First Posted: July 21, 2011
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Yan Chai Hospital:
Palliative Care
Advanced Cancer
Constipation
Traditional Chinese Medicine
Syndrome Distribution

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms