UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051086 |
|---|---|
| Receipt number | R000057571 |
| Scientific Title | Extremity Cryocompression Therapy for Symptom Relief in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunochemotherapy Including Carboplatin, Taxanes, and Immune Checkpoint Inhibitors |
| Date of disclosure of the study information | 2023/05/17 |
| Last modified on | 2023/05/17 14:03:23 |
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Basic information
Public title
Extremity Cryocompression Therapy for Symptom Relief in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunochemotherapy Including Carboplatin, Taxanes, and Immune Checkpoint Inhibitors
Acronym
Extremity Cryocompression Therapy for Symptom Relief in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunochemotherapy Including Carboplatin, Taxanes, and Immune Checkpoint Inhibitors
Scientific Title
Extremity Cryocompression Therapy for Symptom Relief in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunochemotherapy Including Carboplatin, Taxanes, and Immune Checkpoint Inhibitors
Scientific Title:Acronym
Extremity Cryocompression Therapy for Symptom Relief in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunochemotherapy Including Carboplatin, Taxanes, and Immune Checkpoint Inhibitors
Region
| Japan |
Condition
Condition
NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and confirm the safety of the use of extremity cold compression therapy to reduce the incidence of CIPN in patients with advanced non-small cell lung cancer receiving a regimen containing CBDCA + taxanes + immune checkpoint inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of CIPN at any grade (CTACAE ver. 5.0)
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform cryocompression therapy of the extremities.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with non-small cell lung cancer based on cytology/histology.
2) Incurable stage III/IV disease or recurrence after curative therapy (surgery, chemoradiotherapy, or radiation therapy alone).
3) No prior chemotherapy (prior use of non-cytotoxic agents such as tyrosine kinase inhibitors is allowed). Cases that received adjuvant chemotherapy or chemoradiotherapy are eligible if the regimen does not include taxanes and the last administration of the final chemotherapy occurred at least 6 months prior to the registration in this trial.
4) Japanese nationals aged 18 years or older (gender is not specified).
5) Study subjects who have received sufficient explanation and have provided written consent of their own free will.
6) Planned treatment regimen includes the following therapy consisting of CBDCA + taxane-based chemotherapy + immune checkpoint inhibitors:
a) KEYNOTE407 regimen: Non-small cell squamous carcinoma lung cancer
CBDCA + Nab-Paclitaxel + Pembrolizumab or CBDCA + Paclitaxel + Pembrolizumab
b) IMpower150 regimen: Non-small cell non-squamous carcinoma lung cancer
CBDCA + Paclitaxel + Bevacizumab + Atezolizumab
c) IMpower130 regimen: Non-small cell non-squamous carcinoma lung cancer
CBDCA + Nab-Paclitaxel + Atezolizumab
d) POSEIDON regimen: Non-small cell lung cancer
CBDCA + Nab-Paclitaxel + Durvalumab + Tremelimumab
Key exclusion criteria
1) Presence of peripheral neuropathy with self-reported symptoms (Common Terminology Criteria for Adverse Events: CTCAE grade 2 or higher), excluding those caused by systemic conditions such as diabetes, connective tissue diseases, uremia, vitamin B1 deficiency, cervical or lumbar spondylosis, etc. Objective tests, such as nerve conduction velocity, are not mandatory for excluding peripheral neuropathy.
2) History of Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy.
3) Presence of tumor-related neuropathy.
4) Presence of cognitive impairment or consciousness disturbance preventing completion of the EORTC QLQ-CIPN20 questionnaire.
5) Presence of open wounds or ulcers in the limbs.
6) Severe peripheral arterial disease.
7) Poorly controlled diabetes (HbA1c > 8.0%) at screening.
8) History of Raynaud's phenomenon.
9) Intolerance to cold.
10) Other reasons determined by the principal investigator that render the patient unsuitable for inclusion in the study.
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory medicine
Zip code
251-0041
Address
1-5-1, Tsujidokandai, Fujisawa
TEL
0466351177
m-hibino@ctmc.jp
Public contact
Name of contact person
| 1st name | Hibino |
| Middle name | |
| Last name | Makoto |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory medicne
Zip code
2510041
Address
1-5-1, Tsujidokandai, Fujisawa
TEL
09091741092
Homepage URL
m-hibino@ctmc.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital, Respiratory medicine, Makoto Hibino
Institute
Department
Personal name
Makoto Hibino
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
homepage@tokushukai.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057571
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
