UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of treatment with compression gloves and compression stockings to prevent paclitaxel-induced peripheral. neuropathy
Title of the study (Brief title)	gloves and stockings to prevent paclitaxel-induced peripheral neuropathy
Region	Japan

Condition
Condition	non small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	By wearing compression gloves and compression stockings at start of chemotherapy, we analyze period to occurrence, frequency, and extent of peripheral neuropathy. We also evaluate relationship among peripheral neuropathy and effect and dose intensity of chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of peripheral neuropathy in the third cycle before starting
Key secondary outcomes	1) period to development of neurotoxicity (grade 2 or more) 2)proportion of cases who experience contra-lateral neuropathy previous to intervention side. 3) grade of neuropathy 4)relationship among proportion of neuropathy and proportion of completion and effect of chemotherapy. 5) safety of compression gloves and compression stockings.

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	May26,2014-May31,2015
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) planning to treat with paclitaxel and nob-paclitaxel. 2) 20 years old or more 3) no neuropahty before enrollment 4) controlled diabetes mellitus (DM) or no DM 5) no significant skin disorder of extremities
Key exclusion criteria	1) any grade of neurotoxicity 2) no ability to express toxicity 3) significant skin disorder of extremites 4) symptomatic brain metastasis
Target sample size	18

Research contact person
Name of lead principal investigator	Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	respiratory medicine
Address	47-1 Nodayama Shiote aza Medeshima Natorishi Miyagi
TEL	022-384-3151
Email	maemondo-ma693@niyagi-pho.jp

Public contact
Name of contact person	Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	respiratory medicine
Address	47-1 Nodayama Shiote aza Medeshima Natorishi Miyagi
TEL	022-384-3151
Homepage URL
Email	maemondo-ma693@niyagi-pho.jp

Sponsor
Institute	Miyagi Cancer center
Institute
Department

Funding Source
Organization	Miyagi Cancer Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 09 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 13 Day
Anticipated trial start date	2014 Year 05 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 21 Day
Last modified on	2016 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016418