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

NCT04669977 | Unknown

• 1 other identifier: N202006058
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy; cyanidin; interleukin; peripheral neuropathy

Outcome Measures

Primary Outcomes (3)

• Visual analog scale (VAS)

  Pain Assessment

  Within 10 weeks

• 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

• Taiwanese version of the Brief Fatigue Inventory (BFI-T)

  Assessment of the severity of CIPN

  Within 10 weeks

Secondary Outcomes (4)

• Heart rate variability

  Within 10 weeks

• General Anxiety Disorder-7 items (GAD-7)

  Within 10 weeks

• Patient Health Questionnaire-9 items (PHQ-9)

  Within 10 weeks

• Inflammation status

  Within 10 weeks

Study Arms (2)

Auxiliary

EXPERIMENTAL

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.

Dietary Supplement: Mulberry juice

Non-auxiliary

NO INTERVENTION

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.

Interventions

Mulberry juice DIETARY_SUPPLEMENT

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.

Auxiliary

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• El-Wui Loh, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

El-Wui Loh, PhD

CONTACT

886-903136037; lohew@hotmail.com

Yun-Yun Chou, PhD

CONTACT

886-0974515039; daliner@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: December 2, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

TW (1)