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Clinical Trial on Palliative Cancer Patients With Constipation

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ClinicalTrials.gov Identifier: NCT02795390
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Caritas Medical Centre, Hong Kong
Yan Chai Hospital
Our Lady of Maryknoll Hospital
Hong Kong Buddhist Hospital
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
ZhaoXiang Bian, Hong Kong Baptist University

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.

Condition or disease Intervention/treatment Phase
Constipation Drug: Chinese herbal medicine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation
Actual Study Start Date : November 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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



Primary Outcome Measures :
  1. Global symptom improvement (improved / same / worse) [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Number of bowel movement (times/day) [ Time Frame: 2 weeks ]
  2. Stool form [ Time Frame: 2 weeks ]
    Stool form is assessed with 7-point Bristol Stool Scale (ranging from "separate hard lumps" to "watery")

  3. Extra laxatives used (times/week) [ Time Frame: 2 week ]
  4. Constipation visual analogue scale [ Time Frame: 2 weeks ]
    The severity of constipation is evaluated by an eight point ordinal rating scale (0=none to 7=most severe)

  5. Constipation related symptoms [ Time Frame: 2 weeks ]
    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)

  6. Adverse events [ Time Frame: 2 weeks ]
  7. Blood creatinine level (umol/L) [ Time Frame: 2 weeks ]
  8. Blood urea level (mmol/L) [ Time Frame: 2 weeks ]
  9. Serum glutamic pyruvic transaminase(SGPT) Level (U/L) [ Time Frame: 2 weeks ]
  10. Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L) [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795390


Locations
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Hong Kong
Caritas Medical Centre
Hong Kong, Hong Kong
Hong Kong Buddhist Hospital
Hong Kong, Hong Kong
Our Lady of Maryknoll Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Hong Kong Baptist University
Caritas Medical Centre, Hong Kong
Yan Chai Hospital
Our Lady of Maryknoll Hospital
Hong Kong Buddhist Hospital
Hospital Authority, Hong Kong
Investigators
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Principal Investigator: Zhao-xiang Bian, PhD Hong Kong Baptist University

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Responsible Party: ZhaoXiang Bian, Chair Professor, Director, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT02795390     History of Changes
Other Study ID Numbers: HKBU/KWC/PC2014
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research results will be published after analysis.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After publication with no time limit
Access Criteria: Open for public
Keywords provided by ZhaoXiang Bian, Hong Kong Baptist University:
Chinese herbal medicine formula
MaZiRenWan
Randomized controlled trial
Constipation
Palliative care in cancer
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms