UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061124 |
|---|---|
| Receipt number | R000069945 |
| Scientific Title | A Clinical Trial to Evaluate the Efficacy of Combining Cooling Therapy and Compression Therapy in Alleviating Taxane-Induced Peripheral Neuropathy in Patients with Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/04/01 14:02:29 |
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Basic information
Public title
Evaluation of the Preventive Effects of Combined Cooling and Compression Therapy on Chemotherapy-Induced Peripheral Neuropathy (CIPN) Caused by Chemotherapy for Lung Cancer Using Taxane-Based Anticancer Drugs
Acronym
HARIMA C2 study
Scientific Title
A Clinical Trial to Evaluate the Efficacy of Combining Cooling Therapy and Compression Therapy in Alleviating Taxane-Induced Peripheral Neuropathy in Patients with Non-Small Cell Lung Cancer
Scientific Title:Acronym
Taxane CIPN - Cooling & Compression
Region
| Japan |
Condition
Condition
Advanced lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Preventive Effects of Combined Cooling and Compression Therapy on Chemotherapy-Induced Peripheral Neuropathy Caused by Taxane-Based Chemotherapy for Lung Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Common Terminology Criteria for Adverse Events (CTCAE) v6.0 CIPN grade assessment 12 weeks after completion of chemotherapy, including taxane-based anticancer agents
Key secondary outcomes
1. Common Terminology Criteria for Adverse Events (CTCAE) v6.0 CIPN grade assessment at the start of each cycle (Day 1)
2. Numerical Rating Scale (NRS) assessment at the start of each cycle (Day 1)
3. Incidence of adverse events
4. Rate of chemotherapy dose reduction or discontinuation due to CIPN
5. Assessment of the European Organisation for Research and Treatment on Cancer (EORTC) QLQ-CIPN20 score at the end of chemotherapy containing taxane-based anticancer agents
6. Assessment of the European Organisation for Research and Treatment on Cancer (EORTC) QLQ-CIPN20 score 12 weeks after the end of chemotherapy containing taxane-based anticancer agents
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
In the intervention group, compression therapy using surgical gloves and cooling therapy using frozen gloves were administered to the hands, while compression therapy using elastic stockings and cooling therapy using frozen socks were administered to the lower limbs, from 30 minutes before to 30 minutes after each course of taxane-based anticancer drug administration.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with advanced lung cancer who are receiving first-line chemotherapy containing taxane-based anticancer agents at one of six facilities in the Harima region, including Himeji St. Mary's Hospital, during the period from the date of study approval through March 31, 2028 (For the purposes of this study, taxane-based anticancer agents refer to paclitaxel or nab-paclitaxel, which are used as standard first-line treatments for lung cancer)
2. Patients aged 18 years or older
3. Patients who can provide informed consent to participate in the trial of their own free will
4. Patients with an ECOG Performance Status of 0 or 1
5. Patients with a life expectancy of six months or more
Key exclusion criteria
1.Patients who declined to participate in this study
2.Patients deemed unsuitable for this study by the principal investigator
3.Patients with limb amputations
4.Patients with peripheral neuropathy due to comorbid conditions such as poorly controlled diabetes, autoimmune neuropathies (e.g., Guillain-Barre syndrome, Fisher syndrome, chronic inflammatory demyelinating polyneuropathy), or cerebrovascular disorders accompanied by incomplete or complete paralysis
5.Patients who have undergone major surgery (surgery requiring spinal anesthesia such as general anesthesia or epidural analgesia, surgery requiring cranial trepanation, or tumor resection, etc.) within 4 weeks prior to obtaining informed consent. However, patients who underwent central venous (CV) port placement within 2 weeks prior to enrollment will not be excluded
6.Patients with a history of trauma or surgery to the fingers or toes within 4 weeks prior to obtaining informed consent
7.Plans to initiate or increase the dosage of the following medications during the study period:
Duloxetine, pregabalin, gabapentin, milogabalin, sodium valproate, phenobarbital, phenytoin, clonazepam, lidocaine, Goshajinkigan, Bushisueki
8.Currently receiving any of the following medications for symptoms other than CIPN:
Duloxetine, pregabalin, gabapentin, milogabalin, sodium valproate, phenobarbital, phenytoin, clonazepam, lidocaine, Goshajinkigan, Bushisueki
9.Participating in clinical trials for other pharmaceuticals or medical devices
10.History of or concurrent mental disorders (alcohol dependence, substance abuse, mood disorders, anxiety disorders, dementia)
11.Women who wish to become pregnant, or women who are pregnant or breastfeeding (a pregnancy test must be performed if there is a possibility of pregnancy)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
670-0801
Address
650 Nitoyono, Himeji City, Hyogo Prefecture
TEL
0792655111
nakajima-y@himemaria.or.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
670-0801
Address
650 Nibuno, Himeji, Hyogo, Japan
TEL
0792655111
Homepage URL
nakajima-y@himemaria.or.jp
Sponsor or person
Institute
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Department of Respiratory Medicine
Yasuhiro Nakajima
Institute
Department
Personal name
Yasuhiro Nakajima
Funding Source
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Department of Respiratory Medicine
Yasuhiro Nakajima
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee
Address
650 Nibuno, Himeji, Hyogo, Japan
Tel
0792655111
di@himemaria.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立はりま姫路総合医療センター(兵庫県)
独立行政法人国立病院機構姫路医療センター（兵庫県）
姫路赤十字病院（兵庫県）
加古川中央市民病院（兵庫県）
北播磨総合医療センター（兵庫県）
社会医療法人財団聖フランシスコ会 姫路聖マリア病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069945
