Clinical Trial on Palliative Cancer Patients With Constipation

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

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.

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