Clinical Trial on Palliative Cancer Patients With Constipation

Study Overview
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Brief Summary
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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.

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

Conditions
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Constipation

Intervention / Treatment
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* Drug: Chinese herbal medicine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese herbal medicine<br>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. | Drug: Chinese herbal medicine<br> <br> |
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bowel movement (times/day) |  | 2 weeks | 
| Stool form | Stool form is assessed with 7-point Bristol Stool Scale (ranging from separate hard lumps to watery) | 2 weeks | 
| Extra laxatives used (times/week) |  | 2 week | 
| 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 | 
| 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 | 
| Adverse events |  | 2 weeks | 
| Blood creatinine level (umol/L) |  | 2 weeks | 
| Blood urea level (mmol/L) |  | 2 weeks | 
| Serum glutamic pyruvic transaminase(SGPT) Level (U/L) |  | 2 weeks | 
| Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L) |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese herbal medicine formula, MaZiRenWan, Randomized controlled trial, Constipation, Palliative care in cancer