UMIN-CTR Clinical Trial

Public title

Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Acronym

Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Scientific Title

Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Scientific Title:Acronym

Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Region

Japan

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

There is no established method for prevention of chemotherapy induced peripheral neuropathy(CIPN). In this study, we assess the effectiveness of compression therapy using surgical gloves(SG) for prevention of CIPN.To put it concretely, we assess the difference of occurrence rates of CIPN by the following method; in each patient, 2 SG that are one size smaller than the size that fit are worn on one hand(compression therapy side;CT side),2 SG that fit the patient's glove size are worn on the other hand(control side)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The difference in the frequency of occurrence of CIPN (motor/sensory) between the CT side hand and the control side hand was determined by the physician in charge using the Common Terminology Criteria for Adverse Events scale version 4.0 (CTCAE v4.0). Grade 2 or more were considered to be CIPN.

Key secondary outcomes

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

For every PTX infusion, each patient wore the 2 smaller SG on one hand (compression therapy side; CT side), and the 2 SG that fit on the other hand (control side) for 90 minutes: the 30 minutes before the administration of PTX, the 30 minutes of PTX infusion itself, and the 30 minutes after the end of the infusion. CT side and control side are blind for both patients and physicians.

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

Female

Key inclusion criteria

1.Who started chemotherapy of wPTX 80mg/m2(plusminus Trastuzumab or Bevacizumab or Pertuzumab plusminus Trastuzumab)
2.ECOG performance status 0 or 1
3.Adequate bone marrow,heart,liver and renal function
4.Informed consent is obtainable from the subject herself in documented form using the Consent Form

Key exclusion criteria

1.Already have peripheral neuropathy >grade 1 by CTCAE v4.0
2.Previous chemotherapy treatment of PTX or nab-PTX
3.The patients whose peripheral intravenous injection is possible only in the area where the gloves are worn
4.History of Raynaud syndrome, hepatitis or other active infectious disease and uncontrolled diabetes
5.Any condition for contraindication of chemotherapy
6.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization)
Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer
7.Active brain metastasis which require immediate medical procedure or radiation therapy
8.Pleural effusion, ascites or pericardial effusion which require immediate medical procedure

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Haruru Kotani

Organization

Aichi Cancer Center

Division name

Department of Breast Oncology

Zip code

Address

1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref

TEL

052-762-6111

Email

k.haruru@aichi-cc.jp

Name of contact person

1st name
Middle name
Last name	Haruru Kotani

Organization

Aichi Cancer Center

Division name

Department of Breast Oncology

Zip code

Address

1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref

TEL

052-762-6111

Homepage URL

Email

k.haruru@aichi-cc.jp

Institute

Aichi Cancer Center

Institute

Department

Personal name

Organization

Aichi Cancer Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

愛知県がんセンター中央病院

Date of disclosure of the study information

2017

Year

06

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2017

Year

05

Month

22

Day

Date of IRB

2017

Year

06

Month

29

Day

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

2019

Year

12

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

26

Day

Last modified on

2019

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032007