Cross Sectional Study of Constipation in Advanced Cancer Patients

Constipation Clinical Trial

Official title:

Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399294
• Other study ID #: Constipation/TCM2010
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: July 19, 2011
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: July 2011
• Source: Yan Chai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Hong Kong Hospital Authority
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: February 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Constipation
• Palliative Care
• Traditional Chinese Medicine

Locations

Country	Name	City	State
China	Caritas Medical Centre	Hong Kong	Hong Kong
China	Our Lady of Maryknoll Hospital	Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Yan Chai Hospital	Hong Kong Baptist University, Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TCM syndrome distribution	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)	No
Secondary	bowel habit	Patient's own reporting or experience of constipation; Effectiveness of current practice in relief of constipation	End of recruitment (estimated timeframe: 3 months)	No