Chemotherapy-induced Peripheral NeuropathyNCT04669977
Effects of a Glucoside- and Rutinoside-rich Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms
A study testing Mulberry juice in people with Chemotherapy-induced Peripheral Neuropathy, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Mulberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
El-Wui Loh, PhD, 886903136037 ext. 886903136037, lohew@hotmail.com
About this study
Official title: Treatment Effects of a Glucoside- and Rutinoside-rich Crude Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms
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.
Read the 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 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.
- Being tested
- Mulberry juice
- Keywords
- Chemotherapy; cyanidin; interleukin; peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry juiceDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Pain Assessment
Measured: 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.
Measured: Within 10 weeks
Taiwanese version of the Brief Fatigue Inventory (BFI-T)
Assessment of the severity of CIPN
Measured: Within 10 weeks
Secondary outcomes (4)
Heart rate variability
Assessment of physiological changes during the research period by using a portable photoplethysmography
Measured: Within 10 weeks
General Anxiety Disorder-7 items (GAD-7)
To measure anxiety levels
Measured: Within 10 weeks
Patient Health Questionnaire-9 items (PHQ-9)
To measure depression levels
Measured: Within 10 weeks
Inflammation status
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.
Measured: Within 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- El-Wui Loh, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669977
- Sponsor's protocol ID
- N202006058
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of a Glucoside- and Rutinoside-rich Crude Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms
- ClinicalTrials.gov ID
- NCT04669977
- Acronym / sponsor ID
- N202006058
- Keywords
- Chemotherapy; cyanidin; interleukin; peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auxiliary | Experimental | Dietary Supplement: Mulberry juiceOne 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. |
| 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulberry juiceOne 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. | Dietary supplement | Auxiliary |
Primary outcome
Visual analog scale (VAS)
Time frame: Within 10 weeks
Pain Assessment
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.
Taiwanese version of the Brief Fatigue Inventory (BFI-T)
Time frame: Within 10 weeks
Assessment of the severity of CIPN
4 secondary outcomes
Heart rate variability
Time frame: Within 10 weeks
General Anxiety Disorder-7 items (GAD-7)
Time frame: Within 10 weeks
Patient Health Questionnaire-9 items (PHQ-9)
Time frame: Within 10 weeks
Inflammation status
Time frame: Within 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El-Wui Loh, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry juice in people with Chemotherapy-induced Peripheral Neuropathy, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El-Wui Loh, PhD (886-903136037, lohew@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: Within 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.