Clinical Trial on Palliative Cancer Patients With Constipation

Hong Kong Baptist University

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: Placebo; Drug: Chinese herbal medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02795390

HKBU/KWC/PC2014

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Chinese herbal medicine

Experimental group

Description:

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.

Treatment:

Drug: Chinese herbal medicine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo