Cross Sectional Study of Constipation in Advanced Cancer Patients

Completed

• Conditions: Palliative Care; Constipation; Traditional Chinese Medicine

• Registration Number: NCT01399294
• Lead Sponsor: Yan Chai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-07
• Study Completion: 2011-02
• Status Verified: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Last Update Submitted: 2011-07-19
• Study First Posted: 2011-07-21
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM syndrome distribution	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

Name	Time	Method
bowel habit	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

Trial Locations

Locations (2)

Caritas Medical Centre; 🇨🇳 Hong Kong, Hong Kong, China

Our Lady of Maryknoll Hospital; 🇨🇳 Hong Kong, Hong Kong, China