Clinical Trial on Palliative Cancer Patients With Constipation

Constipation Clinical Trial

Official title:

Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795390
• Other study ID #: HKBU/KWC/PC2014
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severity of constipation > 3 points (an 8-point scale from 0 to 7)

• Palliative Performance Scale =60%

• Relatively stable liver and renal function within 3 months

• Patients who can read and speak Chinese

Exclusion Criteria:

• Inability to communicate

• Presence of a colostomy, or gastrointestinal obstruction

• Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement > 3/day under routine laxative treatment

• History of Chinese herbal medicine allergies

• Estimated life expectancy less than 1 month

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Chinese herbal medicine

• Placebo

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Caritas Medical Centre, Hong Kong Buddhist Hospital, Hospital Authority, Hong Kong, Our Lady of Maryknoll Hospital, Yan Chai Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global symptom improvement (improved / same / worse)	Participants are asked to rate their impression of change in constipation symptoms in comparison with their baseline, with scores from 0 to 6 represents markedly worse or better at the respective extremes. The response categories are collapsed to simply "improved" for score 4-6, "same" for score 3, or "worse" for score 0-2.	2 weeks
Secondary	Number of bowel movement (times/day)		2 weeks
Secondary	Stool form	Stool form is assessed with 7-point Bristol Stool Scale (ranging from "separate hard lumps" to "watery")	2 weeks
Secondary	Extra laxatives used (times/week)		2 week
Secondary	Constipation visual analogue scale	The severity of constipation is evaluated by an eight point ordinal rating scale (0=none to 7=most severe)	2 weeks
Secondary	Constipation related symptoms	Sensation of straining, incomplete evacuation, bloating, abdominal pain/cramping, nausea, and passing of gas are recorded using a 7-point ordinal scale (0=not at all and 6=very severe)	2 weeks
Secondary	Adverse events		2 weeks
Secondary	Blood creatinine level (umol/L)		2 weeks
Secondary	Blood urea level (mmol/L)		2 weeks
Secondary	Serum glutamic pyruvic transaminase(SGPT) Level (U/L)		2 weeks
Secondary	Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L)		2 weeks