- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04669977
Effects of a Glucoside- and Rutinoside-rich Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms
Treatment Effects of a Glucoside- and Rutinoside-rich Crude Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: El-Wui Loh, PhD
- Phone Number: 886-903136037
- Email: lohew@hotmail.com
Study Contact Backup
- Name: Yun-Yun Chou, PhD
- Phone Number: 886-0974515039
- Email: daliner@tmu.edu.tw
Study Locations
-
-
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New Taipei City, Taiwan, 235
- Recruiting
- Taipei Medical University Shuang Ho Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients are eligible for study 1 (水ffects of mulberry juice on pain and CIPN in participants with severe pain) if they have any cancer and are receiving the oxaliplatin or taxanes (paclitaxel and docetaxel) containing regimen weekly. Other inclusion criteria are (1) age ≥20 and <75 years; (2) performance status (PS) 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale; (3) life expectancy > 2 months. Visual analog scale (VAS) ≥4. Subjects for study 2 (水ffects of mulberry juice on fatigue, anxiety, and depression in participants with moderate pain) must meet all criteria above with the exception that the VAS should be <4.
Exclusion Criteria:
Patients are excluded if they (1) are not communicable; (2) have received radiotherapy within 4 weeks and cardiac dysfunction due to prior anthracyclines; (3) have symptomatic brain metastasis, symptomatic fluid retention, or severe comorbidities such as uncontrolled diabetes mellitus, severe hypertension or infection; (4) have psychiatric or social conditions that would prevent compliance with treatment, follow-up or adequate informed consent. Pregnant or lactating females are also ineligible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auxiliary
One bottle (600ml/bottle) of sanitized mulberry juice would be sent to participants of the auxiliary group with instructions to consume 50ml of juice diluted with drinking water at room temperature.
They are expected to finish the mulberry juice in 10 to 11 days.
Measurements of clinical symptoms and blood sampling are conducted on day 1 of every other week for 5 weeks.
If clinical measurements or blood extractions fail or miss, a substitute assessment or blood sample will be obtained on day 2 or day 3.
The research period for these participants is 29 days (4 weeks).
The checkpoints are arranged because patients with oxaliplatin treatment visit the clinic every two weeks, and patients with paclitaxel treatment visit the clinic every week.
For patients having docetaxel therapy, the research period is 43 days (6 weeks) because docetaxel is administered every three weeks.
|
One bottle (600ml/bottle) of sanitized mulberry juice would be sent to participants of the auxiliary group with instructions to consume 50ml of juice diluted with drinking water at room temperature.
Also, a reminder of the next clinical visit is attached.
They are expected to finish the mulberry juice in 10 to 11days instead of 12 days.
|
No Intervention: Non-auxiliary
For the non-auxiliary group (control group), patients are informed of their allocation results and they will not consume mulberry juice during the research period but will receive the mulberry juice after the research period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale (VAS)
Time Frame: Within 10 weeks
|
Pain Assessment
|
Within 10 weeks
|
Taiwanese version of Neuropathic pain symptom inventory (NPSI-T)
Time Frame: Within 10 weeks
|
To evaluate the detail of pain of the patients, such as the quality of pain, numbness and tingling.
|
Within 10 weeks
|
Taiwanese version of the Brief Fatigue Inventory (BFI-T)
Time Frame: Within 10 weeks
|
Assessment of the severity of CIPN
|
Within 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: Within 10 weeks
|
Assessment of physiological changes during the research period by using a portable photoplethysmography
|
Within 10 weeks
|
General Anxiety Disorder-7 items (GAD-7)
Time Frame: Within 10 weeks
|
To measure anxiety levels
|
Within 10 weeks
|
Patient Health Questionnaire-9 items (PHQ-9)
Time Frame: Within 10 weeks
|
To measure depression levels
|
Within 10 weeks
|
Inflammation status
Time Frame: Within 10 weeks
|
Evaluated by measuring CRP, known cytokines (IL-6, IL-1β, TNF-α, G-CSF, GM-CSF, and TGF-β), chemokines (IL-8, GRO-α, and MCP-1), and PGE in sera, in addition to the sentinel molecule IL-17A.
|
Within 10 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202006058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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