Clinical Trial on Palliative Cancer Patients With Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Chinese herbal medicine

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Chinese herbal medicine

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No