The double-blind randomized control trial to relief the diStress from cheMotherapy-Induced peripheraL nEurophathy by magnetic field

JRCT ID: jRCT2032220295

Registered date:26/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chemotherapy-induced peripheral neuropathy
• Date of first enrollment: 14/09/2022
• Target sample size: 38
• Study type: Interventional

Intervention(s)

Assignment by randomization to ensure comparability with the control group, the Sham machine.
1.1-28 cases
All patients will have the conductors of the study device applied to a total of 4 sites in both axillae and both groin regions for 30 minutes per session, at least twice a day (maximum of 2 hours), for 84 days.
2. 29-38 cases
All patients will have the conductors of the study device applied to the four most symptomatic areas of both palms and both soles, for 30 minutes per session, at least twice a day (maximum of 2 hours) for 84 days.

Outcome(s)

• Primary Outcome: The change of average pain (NRS) at Day 85

Secondary Outcome

1. The change of average pain (NRS) at Day8, Day15, Day 22, Day29, Day57, and Day113
2. The change of score of EORTC QLQ-C30 and QLQ-CIPN20 at Day15, Day29, Day57, Day85, and Day113
3. The change in tingling, numbness (NRS) at Day8, Day15, Day 22, Day29, Day57, Day85, and Day113
4. Patient Global Impression of Change (PGI-C) for Day 15, Day 29, Day 57, and Day 85
5. Incidence of adverse events (CTCAE v.5.0)
6. Occurrence of failure of investigational device

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Aged 18 to 80 years old

2. Satisfy all of the following
1) 24-hour average pain (NRS, Numeric Rating Scale) on the CIPN is 4 or higher
2) Peripheral sensory neuropathy greater than CTCAE v5.0 grade 1 in any of the extremities

3.Satisfy either of the following
1) At least 12 weeks since the last administration of paclitaxel or nab-paclitaxel in perioperative adjuvant chemotherapy for breast cancer and not receiving any treatment other than hormonal therapy
At least 4 weeks since the last administration of all cancer chemotherapies exclusing Hormone therapies

2) At least 12 weeks since the date of the last administration of oxaliplatin in perioperative adjuvant chemotherapy for colorectal cancer and not receiving any treatment
At least 4 weeks since the since the last administration of all cancer chemotherapies

4. Have not received treatment for CIPN or receiving stable regular treatments (including drug prescription, dosage, administration) for 14 days prior to informed consent

5. Stable CIPN symptom severity for 14 days prior to informed consent

6. ECOG performance status (PS) of 0, 1 or 2

7. Life expectancy of >= 12 weeks after enrollment

8. No hospitalization required for treatment

9. Written informed consent

Exclude criteria

1. Stage IV

2. Edema limbs greater than CTCAE v5.0 grade 1

3. limb loss

4. Inability to apply a pad due to skin lesions in the area where the pad is to be applied (axilla and groin, or palms and soles)

5. New or increased doses of any of the following drugs are planned during the study period
Duloxetine, Pregabalin, Gabapentin, Mirogabalin, Sodium valproate, Phenobarbital, Phenytoin, Clonazepam, Lidocaine, Goshajinkigan, Powdered processed aconite root

6. The following drugs are administered for symptoms other than CIPN
Duloxetine, Pregabalin, Gabapentin, Mirogabalin, Sodium valproate, Phenobarbital, Phenytoin, Clonazepam, Lidocaine, Goshajinkigan, Powdered processed aconite root

7. History of trauma or surgery to fingers or toes within 4 weeks prior to informed consent

8. Comorbidities presenting with peripheral neuropathy such as poorly controlled diabetes mellitus, autoimmune neuropathies (Guillain-Barre syndrome, Fisher syndrome, chronic inflammatory demyelinating polyneuropathy, etc.), cerebrovascular disease with incomplete or complete paralysis

9. Major surgery (such as surgery requiring general anesthesia or spinal analgesia such as epidural analgesia, surgery requiring perforation of the cranium, or removal of a tumor) within 4 weeks prior to informed consent
However, CV port construction is not excluded unless performed within 2 weeks prior to enrollment.

10. Using life-supporting medical electrical equipment such as a heart-lung machine and pacemaker, or wearable medical electrical equipment such as an electrocardiograph

11. Participating in clinical trials of other drugs or medical devices

12. Unable to complete the survey form or patient diary due to pain or numbness in the fingers

13. History or comorbidity of psychiatric disorders (alcoholism, drug abuse, mood disorders, anxiety disorders, dementia)

14. Women who wish to become pregnant or who are pregnant or lactating (a pregnancy test should be performed if there is a possibility of pregnancy)

15. Judged by the investigator or sub-investigator to be ineligible for enrollment in the study

Related Information

• Primary Sponsor: Kubo Emi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development