Status:
UNKNOWN
Effects of a Glucoside- and Rutinoside-rich Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms
Lead Sponsor:
Taipei Medical University
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
Chemotherapy-induced peripheral neuropathy (CIPN is common among cancer patients during or after chemotherapy, and the currently available drugs cannot effectively manage the symptoms. Besides, CIPN c...
Detailed Description
Cancer is at least partially attributable to immunological disturbance, and its treatment causes additional inflammatory problems. Chemotherapy-induced peripheral neuropathy (CIPN), especially that in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04669977
Start Date
December 2 2020
End Date
December 1 2023
Last Update
December 17 2020
Active Locations (1)
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1
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan, 235