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Completed

NCT Number: NCT01399294

Cross Sectional Study of Constipation in Advanced Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caritas Medical Centre, Hong Kong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. bowel habit

    Time frame: End of recruitment (estimated timeframe: 3 months)

    • Patient's own reporting or experience of constipation
    • Effectiveness of current practice in relief of constipation

Sponsors and collaborators

Lead sponsor

Yan Chai Hospital

Other

Collaborators

  • Hong Kong Baptist University
  • Hospital Authority, Hong Kong

Registry information

Official study title

Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 21, 2011
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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