Clinical trial NCT02795390: Clinical Trial on Palliative Cancer Patients With Constipation
Official title: Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: Chinese herbal medicine formula
MaZiRenWan
Randomized controlled trial
Constipation
Palliative care in cancer
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Caritas Medical Centre, Hong Kong
name: Yan Chai Hospital
name: Our Lady of Maryknoll Hospital
name: Hong Kong Buddhist Hospital
name: Hospital Authority, Hong Kong
First posted: 2016-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Global symptom improvement (improved / same / worse)
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of bowel movement (times/day)
timeFrame: 2 weeks
measure: Stool form
timeFrame: 2 weeks
measure: Extra laxatives used (times/week)
timeFrame: 2 week
measure: Constipation visual analogue scale
timeFrame: 2 weeks
measure: Constipation related symptoms
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 2 weeks
measure: Blood creatinine level (umol/L)
timeFrame: 2 weeks
measure: Blood urea level (mmol/L)
timeFrame: 2 weeks
measure: Serum glutamic pyruvic transaminase(SGPT) Level (U/L)
timeFrame: 2 weeks
measure: Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Caritas Medical Centre
city: Hong Kong
country: Hong Kong
facility: Hong Kong Buddhist Hospital
city: Hong Kong
country: Hong Kong
facility: Our Lady of Maryknoll Hospital
Study officials:
affiliation: Hong Kong Baptist University
name: Zhao-xiang Bian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.