UMIN-CTR Clinical Trial

Public title

A study of the efficacy of frozen glove and socks for prevention of chemotherapy-induced peripheral neuropathy

Acronym

Cryotherapy for prevention of peripheral neuropathy

Scientific Title

A study of the efficacy of frozen glove and socks for prevention of chemotherapy-induced peripheral neuropathy

Scientific Title:Acronym

Cryotherapy for prevention of peripheral neuropathy

Region

Japan

Condition

Cancer

Classification by specialty

Hematology and clinical oncology	Breast surgery	Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To study the efficacy of frozen glove and socks to prevent chemotherapy induced peripheral neuropathy (CIPN), and search for risk factor of CIPN.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Incidence of CIPN(tactile sensation threshold) assessed at each cycle.

Key secondary outcomes

Vibration threshold
Threshold of temperature perception
Hand function
Nerve conduction velocity
Somatosensory evoked potential
Current perception threshold
Patient Neurotoxicity Questionnaire
Acute pain
Adverse events and tolerability (CIPN or other events)
Discomfort with cooling
(pain / paresthesia / arthritis / other)
Demand of cryotherapy for both hands

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Patients wear frozen gloves and socks on their dominant hand and foot from the second chemotherapy to the end of it, as the following process.
1. Gloves and socks will be frozen for over 3 hours in less than -30 degrees.
2. Fifteen minutes before the paclitaxel infusion, each patient will wear the frozen glove and sock on his or her dominant side. The non-dominant side acts as an untreated control.
3. After 45 minutes of wearing them, they will be replaced with a new frozen glove and sock.
4. Fifteen minutes after the infusion of paclitaxel, the patient will remove the sock and glove.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Scheduled to receive weekly paclitaxel (at 80mg/m2 via 1-hour infusion) at least 4weeks.
2. 20 years of age or over.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
4. Patients who gave written informed consent.

Key exclusion criteria

1. Peripheral sensory/motor neuropathy, neuralgia or edema of limb which were graded 2 or higher (CTCAE ver4.0)
2. Presence of metastasis in the bone, soft tissue or skin of the hands or foot
3. Patient with finger or toe defect
4. Not suitable for participation with Raynaud's symptoms,peripheral arterial ischemia, hand-foot syndrome, or any other reasons.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Tadao Tsuboyama

Organization

Kyoto university graduate school of medicine

Division name

Human Health Science

Zip code

Address

53, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto

TEL

075-751-3948

Email

tsubo@hs.med.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Akiko Hanai

Organization

Kyoto university graduate school of medicine

Division name

Human Health Science

Zip code

Address

53, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto

TEL

075-751-3944

Homepage URL

Email

hanai.akiko.44w@st.kyoto-u.ac.jp

Institute

Kyoto university

Institute

Department

Personal name

Organization

Cancer professional training base promotion plan

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Japan Society for the Promotion of Science

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院（京都府）

Date of disclosure of the study information

2014

Year

03

Month

11

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://academic.oup.com/jnci/article/110/2/141/4443215

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

03

Month

26

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

19

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

2016

Year

09

Month

18

Day

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

11

Day

Last modified on

2018

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015629