Cross Sectional Study of Constipation in Advanced Cancer Patients

July 19, 2011 updated by: Yan Chai Hospital

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.

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

255

Contacts and Locations

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

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Caritas Medical Centre
      • Hong Kong, Hong Kong, China
        • Our Lady of Maryknoll Hospital

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

Advanced cancer patients (aged 18 or above) under the care of palliative care units who are on laxatives and who have constipation during recruitment.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of recruitment (estimated timeframe: 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of recruitment (estimated timeframe: 3 months)

Collaborators and Investigators

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

Sponsor

Yan Chai Hospital

Collaborators

Hospital Authority, Hong Kong
Hong Kong Baptist University

Investigators

  • Principal Investigator: Doris MW Tse, MD, Department of Medicine & Geriatrics / ICU, Caritas Medical Centre

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

May 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Constipation/TCM2010

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.

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