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

NCT ID: NCT04669977

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Keywords

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Chemotherapy; cyanidin; interleukin; peripheral neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mulberry juice

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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El-Wui Loh, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

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Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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El-Wui Loh, PhD

Role: CONTACT

Phone: 886-903136037

Email: [email protected]

Yun-Yun Chou, PhD

Role: CONTACT

Phone: 886-0974515039

Email: [email protected]

Facility Contacts

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El-Wui Loh, PhD

Role: primary

Other Identifiers

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N202006058

Identifier Type: -

Identifier Source: org_study_id