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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: Placebo; Drug: Chinese herbal medicine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Caritas Medical Centre
  • Hong Kong, Hong Kong
    • Our Lady of Maryknoll Hospital
  • Hong Kong, Hong Kong
    • Hong Kong Buddhist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Chinese herbal medicine
PLACEBO_COMPARATOR: 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.	Drug: Placebo

What is the study measuring?

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
Adverse events		2 weeks
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
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

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Collaborators: Hospital Authority, Hong Kong; Caritas Medical Centre, Hong Kong; Our Lady of Maryknoll Hospital; Yan Chai Hospital; Hong Kong Buddhist Hospital

Publications and helpful links

General Publications

• Cheng CW, Mok HF, Yau CWS, Chan JTM, Kang YC, Lam PY, Zhong LLD, Zhao C, Ng BFL, Kwok AOL, Tse DMW, Bian ZX. A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients. Chin Med. 2022 Mar 2;17(1):31. doi: 10.1186/s13020-022-00580-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): August 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Constipation; Randomized controlled trial; Chinese herbal medicine formula; MaZiRenWan; Palliative care in cancer
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: HKBU/KWC/PC2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research results will be published after analysis.
• IPD Sharing Time Frame: After publication with no time limit
• IPD Sharing Access Criteria: Open for public
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF