Clinical Trial on Palliative Cancer Patients With Constipation

NCT02795390 | Completed Phase 2 DMC

• 1 other identifier: HKBU/KWC/PC2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Constipation

Keywords

Chinese herbal medicine formula; MaZiRenWan; Randomized controlled trial; Constipation; Palliative care in cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of bowel movement (times/day)

  2 weeks

• Stool form

  2 weeks

• Extra laxatives used (times/week)

  2 week

• Constipation visual analogue scale

  2 weeks

• Constipation related symptoms

  2 weeks

Study Arms (2)

Chinese herbal medicine

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Chinese herbal medicine DRUG

Chinese herbal medicine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Caritas Medical Centre, Hong Kong: collaborator
• Yan Chai Hospital: collaborator
• Our Lady of Maryknoll Hospital: collaborator
• Hong Kong Buddhist Hospital: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (3)

Caritas Medical Centre

Hong Kong, Hong Kong

Location

Hong Kong Buddhist Hospital

Hong Kong, Hong Kong

Location

Our Lady of Maryknoll Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35236375 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhao-xiang Bian, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor, Director

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 10, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication with no time limit
• Access Criteria: Open for public

Locations

HK (3)