Clinical Trial on Palliative Cancer Patients With Constipation

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: Chinese herbal medicine; Drug: Placebo

• Registration Number: NCT02795390
• Lead Sponsor: Hong Kong Baptist University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Study Start: 2016-11
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese herbal medicine	Chinese herbal medicine	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. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Global symptom improvement (improved / same / worse)	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of bowel movement (times/day)	2 weeks
Extra laxatives used (times/week)	2 week
Stool form	2 weeks	Stool form is assessed with 7-point Bristol Stool Scale (ranging from "separate hard lumps" to "watery")
Constipation visual analogue scale	2 weeks	The severity of constipation is evaluated by an eight point ordinal rating scale (0=none to 7=most severe)
Constipation related symptoms	2 weeks	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)
Blood urea level (mmol/L)	2 weeks
Adverse events	2 weeks
Blood creatinine level (umol/L)	2 weeks
Serum glutamic pyruvic transaminase(SGPT) Level (U/L)	2 weeks
Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L)	2 weeks

Trial Locations

Locations (3)

Hong Kong Buddhist Hospital; 🇭🇰 Hong Kong, Hong Kong

Caritas Medical Centre; 🇭🇰 Hong Kong, Hong Kong

Our Lady of Maryknoll Hospital; 🇭🇰 Hong Kong, Hong Kong