Bladder Cancer, Herbal Interaction, Intravenous Drug Usage, Lower Urinary Tract Symptoms
Conditions
Keywords
Intravesical installaion, Bladder cancer, Lower urinary tract symptoms, JING SI HERBAL TEA
Brief summary
To identify the effects of JING SI HERBAL TEA in the treatment of lower urinary tract symptoms after intravesical therapy in patients with bladder cancer.
Detailed description
The patients with bladder cancer usually required trans urethral resection of bladder tumor (TUR-BT). Post-operative intravesical installation therapy is standard therapy. However, new onset lower urinary tract symptoms often occurred after these installation therapies. JING SI HERBAL TEA is a food contain of many herbal extracts with anti-inflammation effects. The current study is to find out the effects of JING SI HERBAL TEA in the treatment of this condition. The patients will be divided into two groups by randomly assigned (estimated case number=100, experimental: control = 1: 1). The first group will receive two sachets of JING SI HERBAL TEA a day (one in the morning and one in the evening). The second group will receive two sachets of placebo a day (same way as group 1). The therapy will be three days after each intravesical installation therapies. The outcome evaluations will use the American Urological Association Symptom Index and 12-Item Short Form Survey (SF-12). The baseline symptoms will be recorded before the first intravesical therapy. Patients will be asked to fill out the questionnaire every week (the same time for the next installation). Every other standard cancer therapies will not be will not be affected.
Interventions
DIETARY_SUPPLEMENTJING SI HERBAL TEA
JING SI HERBAL TEA is a food, contain with herbal extracts
DIETARY_SUPPLEMENTPlacebo
Placebo will have the same appearance as JING SI HERBAL TEA
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients will be randomly assigned into the two groups with equal number. The JING SI HERBAL TEA and placebo have the same outer packaging. One dedicated researcher will be responsible for random allocation and administration, neither the patients nor the attending physicians (responsible for recording symptoms) knows the correct grouping.
Intervention model description
Double Blind (patients and attending physicians), parallel design Experimental group: JING SI HERBAL TEA, twice a day, every time 1 sachet for 3 days after each intravesical installation Control group: Placebo, twice a day, every time 1 sachet for 3 days after each intravesical installation
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis bladder cancer * Under intravesical installation therapy
Exclusion criteria
* Patients under 20 years old or greater than 100 years old * Women with pregnancy or breastfeeding plans * Bladder cancer are being treated in another hospital * Had admitted due to other disease in the past 3 months * Unable to understand the questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary symptoms | The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks | Change from baseline score at the following time will be recorded. The American urological association symptom index is a 7-item self report measure to assess the urinary symptoms. The score range from 0 to 35, the higher the severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life quality | The outcome evaluation will be at the following time points: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks | Change from baseline score at the following time will be recorded. The 12-item shor form survey is a general health questionaire for life quality evaluation. The higher the value obtained, the more significant the impact on life. |
Countries
Taiwan
Outcome results
None listed