Effects of a Glucoside- and Rutinoside-rich Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

Treatment Effects of a Glucoside- and Rutinoside-rich Crude Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04669977
• Other study ID #: N202006058
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2020
• Source: Taipei Medical University
• Contact: El-Wui Loh, PhD
• Phone: 886-903136037
• Email: lohew[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 causes fatigue, anxiety, and depression. CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. We plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

Description:

Cancer is at least partially attributable to immunological disturbance, and its treatment causes additional inflammatory problems. Chemotherapy-induced peripheral neuropathy (CIPN), especially that induced by oxaliplatin or Taxanes (including paclitaxel and docetaxel) is common among cancer patients during or after the treatment of chemotherapeutic agents, presented as pain and sensory abnormalities for months, and even persists for years in some patients after the cessation of chemotherapy. Even worse is that currently available drugs cannot effectively manage these conditions. Besides, CIPN causes fatigue, anxiety, and depression, which lower patients' quality of life and determination to fight the disease. Interestingly, CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor and works in an animal model of skin hyperplasia in reducing the IL-17 levels and severity of hyperplasia. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. Preliminary findings of an ongoing human study of our team have provided statistical evidence that this crude material effectively relieves clinical symptoms of a disorder associated with inflammation features. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. To avoid confounding effects from pain, we plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

Patients are eligible for study 1 (?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 (?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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Dietary Supplement:
• Mulberry juice
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS)	Pain Assessment	Within 10 weeks
Primary	Taiwanese version of Neuropathic pain symptom inventory (NPSI-T)	To evaluate the detail of pain of the patients, such as the quality of pain, numbness and tingling.	Within 10 weeks
Primary	Taiwanese version of the Brief Fatigue Inventory (BFI-T)	Assessment of the severity of CIPN	Within 10 weeks
Secondary	Heart rate variability	Assessment of physiological changes during the research period by using a portable photoplethysmography	Within 10 weeks
Secondary	General Anxiety Disorder-7 items (GAD-7)	To measure anxiety levels	Within 10 weeks
Secondary	Patient Health Questionnaire-9 items (PHQ-9)	To measure depression levels	Within 10 weeks
Secondary	Inflammation status	Evaluated by measuring CRP, known cytokines (IL-6, IL-1ß, TNF-a, G-CSF, GM-CSF, and TGF-ß), chemokines (IL-8, GRO-a, and MCP-1), and PGE in sera, in addition to the sentinel molecule IL-17A.	Within 10 weeks