Cross Sectional Study of Constipation in Advanced Cancer Patients

NCT01399294 | Completed DMC

• 1 other identifier: Constipation/TCM2010
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 2

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.

Conditions

Palliative Care; Constipation; Traditional Chinese Medicine

Keywords

Palliative Care; Advanced Cancer; Constipation; Traditional Chinese Medicine; Syndrome Distribution

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• bowel habit

  End of recruitment (estimated timeframe: 3 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• unable to communicate
• cognitive impaired
• put on colostomy bag
• clinically diagnosed gastrointestinal obstruction
• at end-of-life

Sponsors & Collaborators

• Yan Chai Hospital: lead
• Hospital Authority, Hong Kong: collaborator
• Hong Kong Baptist University: collaborator

Study Sites (2)

Caritas Medical Centre

Hong Kong, Hong Kong, China

Location

Our Lady of Maryknoll Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Doris MW Tse, MD

  Department of Medicine & Geriatrics / ICU, Caritas Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 21, 2011
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

CN (2)