Unique ID issued by UMIN | UMIN000030536 |
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Receipt number | R000034856 |
Scientific Title | A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients. |
Date of disclosure of the study information | 2017/12/24 |
Last modified on | 2019/12/25 02:16:31 |
A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate of the prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nanoparticle albumin-bound(nab)-paclitaxel-induced peripheral neuropathy.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
The incidence of grade 2 or higher nab-paclitaxel-induced peripheral neuropathy.
Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy.
1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control.
2.Withdrawal of intervention procedures
3.Adverse events of interventional procedures
4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.)
5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Device,equipment |
During chemotherapy, wear a frozen glove on one hand and a surgical glove on the other hand continuously, as for frozen glove from 15 minutes before the start of administration of nab-PTX until 15 minutes after the end of the infusion (60 minutes), as for surgical glove from 30 minutes before the start of administration of nab-PTX until 30 minutes after the end of the infusion (90 minutes).
For hands wearing frozen gloves or surgical gloves, "dominant hand" is assigned randomly as the allocation factor.
Using the thermography, the fingertip
temperature of both hands before and after wearing the glove was measured.
20 | years-old | <= |
Not applicable |
Female
Women with pathologically proven primary or recurrent breast cancer, 20 years of age and older
No peripheral sensory/motor neuropathy or Grade 1 peripheral sensory/motor neuropathy without left/right differences
Patients who can answer Japanese questionnaire without assistance
With written informed consent
With allergy for material of frozen globe and surgical glove
Patients with neuropathic pain due to diseases such as diabetes and herpes zoster
34
1st name | Yuko Kanbayashi |
Middle name | |
Last name | Kanbayashi |
Kyoto Prefectural University of Medicine
Outpatient Oncology Unit
602-8566
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
075-251-5111
ykokanba@koto.kpu-m.ac.jp
1st name | Yuko |
Middle name | |
Last name | Kanbayashi |
Kyoto Prefectural University of Medicine
Outpatient Oncology Unit
602-8566
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
075-251-5111
ykokanba@koto.kpu-m.ac.jp
Department of Outpatient Oncology Unit, Kyoto Prefectural University of Medicine
None
Self funding
Kyoto Prefectural University of Medicine
Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
京都府立医科大学附属病院(京都府)
Kyoto Prefectural University of Medicine Hospital(Kyoto)
2017 | Year | 12 | Month | 24 | Day |
Unpublished
Completed
2017 | Year | 07 | Month | 11 | Day |
2017 | Year | 07 | Month | 25 | Day |
2017 | Year | 08 | Month | 29 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 05 | Month | 31 | Day |
2017 | Year | 12 | Month | 23 | Day |
2019 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034856
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