Multicenter prospective registration and intervention studies for chemotherapy-induced peripheral neuropathy

JRCT ID: jRCTs031210101

Registered date:20/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chemotherapy-induced peripheral neuropathy
• Date of first enrollment: 20/05/2021
• Target sample size: 275
• Study type: Interventional

Intervention(s)

Administration of Mirogabalin after enrollment is as written below in accordance with the package insert;
For patients aged 20 years or older, Mirogabalin is generally administrated in dose of 5 mg twice a day at the first. After that, Mirogabalin is gradually increased by 5 mg at intervals of 1 week or more, and finally, Mirogabalin is administrated in dose of 15 mg twice a day.
The dose is adjusted according to the patient's age and symptoms in the range of 10 mg to 15 mg twice a day.

Outcome(s)

Primary Outcome

Registry study
Percentage of cases with peripheral sensory neuropathy (CTCAE version 5.0 grade 2 or higher) at 12 months after the chemotherapy start

Interventional study
Amount of change in the last 7-day pain (including tingling) NRS for 3 months after the administration start of Mirogabalin Besilate

Secondary Outcome

Registry study
(1) Severity of peripheral sensory neuropathy (CTCAE version 5.0 Grade) at 1, 2, 3, 6, 9, 12 months after the chemotherapy start
(2) FACT/GOG NTx (Functional Assessment of Cancer Therapy-Gynecologic Oncology Group Neurotoxicity) at 1, 2, 3, 6, 9, 12 months after the chemotherapy start
(3) Modified TNSr (Modified 5-component Total Neuropathy Score-reduced) at 3, 6, 12 months after the chemotherapy start
(4) EQ-5D-5L at 1, 2, 3, 6, 9, 12 months after the chemotherapy start
(5) Pain (including tingling) NRS (Numerical Rating Scale) at 1, 2, 3, 6, 9, 12 months after the chemotherapy start
(6) Tingling NRS at 1, 2, 3, 6, 9, 12 months after the chemotherapy start
(7) Sleep NRS at 1, 2, 3, 6, 9, 12 months after the chemotherapy start
(8) CIPN risk factors analysis
(9) CIPN frequently appeared time analysis

Interventional study
(1) Amount of change in severity of peripheral sensory neuropathy (CTCAE version 5.0 Grade) at 1, 3 months after the baseline (administration start of Mirogabalin Besilate)
(2) Amount of change in FACT/GOG NTx at 1, 3 months after the baseline (administration start of Mirogabalin Besilate)
(3) Amount of change in Modified TNSr at 1, 3 months after the baseline (administration start of Mirogabalin Besilate)
(4) Amount of change in EQ-5D-5L at 1, 3 months after the baseline (administration start of Mirogabalin Besilate)
(5) Amount of change in pain (including tingling) NRS at 1 month after the baceline (administration start of Mirogabalin Besilate)
(6) Amount of change in tingling NRS at 1, 3 months after the baseline (administration start of Mirogabalin Besilate)
(7) Amount of changes in sleep NRS at 1, 3 months after the baseline (administration start of Mirogabalin Besilate)
(8) PGIC at 3 months after the baseline (administration start of Mirogabalin Besilate)
(9) Percentage of cases of dose reduction, cessation and discontinuation of chemotherapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Registry study
(1) Patients aged 20 years or older at informed consent
(2) The following cancer patients who are scheduled to have chemotherapy with Oxaliplatin or Taxane anticancer drugs within 14 days after the enrollment
-Colorectal cancer (scheduled to be treated according to regimens including Oxaliplatin)
-Gastric cancer (scheduled to be treated according to regimens including Oxaliplatin or Taxane anticancer drugs)
-Non-small cell lung cancer (scheduled to be treated according to regimens including Taxane anticancer drugs)
-Breast cancer (scheduled to be treated according to regimens including Taxane anticancer drugs)
(3) Patients who have voluntarily agreed in writing to participate in this study after receiving sufficient explanations from their study doctors and adequately understanding this study

Interventional study
(1) Patients aged 20 years or older at informed consent
(2) Colorectal, gastric, non-small cell lung, or breast cancer patients who are under chemotherapy treatment according to regimens including Oxaliplatin or Taxane anticancer drugs, and recognized to have chemotherapy-induced peripheral sensory neuropathy (CTCAE version 5.0 grade 2 or higher)
(3) Patients whose CIPN-induced pain (including tingling) NRS at enrollment is 4 or higher
(4) Patients who have voluntarily agreed in writing to participate in this study after receiving sufficient explanations from their study doctors and adequately understanding this study

Exclude criteria

Registry study
(1) Patients who have severe diabetes [HbA1c (NGSP) > 8.4%]
(2) Patients who have alcohol polydipsia history or alcoholism
(3) Patients who have severe cervical or lumbar spondylosis
(4) Patients with poor prognosis
(5) Patients whose CIPN-induced pains are difficult to be assessed due to the pains caused by the other diseases or factors
(6) Patients who are considered inappropriate for this study by Principal investigators or Sub investigators

Interventional study
(1) Patients whose CIPN-induced pains are difficult to be assessed due to the pains caused by the other diseases or factors
(2) Pregnant, possibly pregnant, or lactating patients
(3) Patients who have severe kidney, heart, or liver diseases
(4) Patients whose latest creatinine clearance (Cockcroft-Gault formula) is under 30 mL/min within 3 months before enrollment
(5) Patients with a history of hypersensitivity of Mirogabalin Besilate
(6) Patients with poor prognosis
(7) Patients whose receiving chemotherapy method is scheduled to be changed within 3 months after enrollment
(8) Patients who are scheduled to have surgery within 3 months after enrollment
(9) Patients who are considered inappropriate for this study by Principal investigators or Sub investigators

Related Information

• Primary Sponsor: Kuwabara Satoshi
• Source(s) of Monetary Support: Daiichi Sankyo.Co., Ltd.