UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019482
Receipt number R000022526
Scientific Title A pilot study to evaluate the efficacy of compression therapy using stockings and sleeves for nab-paclitaxel/gemcitabine-induced peripheral neuropathy in unresectable pancreatic cancer patients.
Date of disclosure of the study information 2015/10/23
Last modified on 2015/10/23 23:07:35

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Basic information

Public title

A pilot study to evaluate the efficacy of compression therapy using stockings and sleeves for nab-paclitaxel/gemcitabine-induced peripheral neuropathy in unresectable pancreatic cancer patients.

Acronym

A pilot study to evaluate the efficacy of compression therapy using stockings and sleeves for nab-paclitaxel/gemcitabine-induced peripheral neuropathy in unresectable pancreatic cancer patients.

Scientific Title

A pilot study to evaluate the efficacy of compression therapy using stockings and sleeves for nab-paclitaxel/gemcitabine-induced peripheral neuropathy in unresectable pancreatic cancer patients.

Scientific Title:Acronym

A pilot study to evaluate the efficacy of compression therapy using stockings and sleeves for nab-paclitaxel/gemcitabine-induced peripheral neuropathy in unresectable pancreatic cancer patients.

Region

Japan


Condition

Condition

unresectable pancreatic cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the efficacy of compression therapy using stockings and sleeves for nab-paclitaxel-induced peripheral neuropathy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence and the level of peripheral neuropathy after 16 weeks.

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Compression therapy using stockings and sleeves

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) Pathologically diagnosed Adenocarcinoma or Adenosquamous carcinoma
(2) Unresectable

(3) No prior chemotherapy for pancreatic cancer
(4) Scheduled to receive nab-paclitaxel / gemcitabine
(5) Aged 20-
(6) Performance Status (PS) 0-1
(7) Patients are judged by investigators with adequate organ function within two weeks
(8) Without history or complication of peripheral neuropathy
(9) With written informed consent

Key exclusion criteria

(1) No prior therapy using oxaliplatin
(2) Intestinal pneumonitis or pulmonary fibrosis
(3) Active infection
(4) Active double cancer
(5) With allergy for material of stockings and sleeves
(6) Using elastic stocking regularly
(7) With server artery dysfunction and congestive heart failure, just after dermal graft, necrosis, sever edema, suppurative disease on the skin
(8) With extreme leg deformity
(9) Administering medicine for thrombosis
(10) Severe nervous disorder or mental disorder.
(11) History of serious drug hypersensitivity or a history of drug allergy
(12) Severe complications
(13) Pregnancy
(14) Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayo Motoya

Organization

Sapporo Medical University

Division name

Department of Gastroenterology Rheumatology and Clinical Immunology

Zip code


Address

S-1, W-16, CHUO-KU, SAPPORO, 060-8543, JAPAN

TEL

011-611-2111

Email

hmasayo@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayo Motoya

Organization

Sapporo Medical University

Division name

Department of Gastroenterology Rheumatology and Clinical Immunology

Zip code


Address

S-1, W-16, CHUO-KU, SAPPORO, 060-8543, JAPAN

TEL

011-611-2111

Homepage URL


Email

hmasayo@sapmed.ac.jp


Sponsor or person

Institute

Department of Gastroenterology Rheumatology and Clinical Immunology, Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology Rheumatology and Clinical Immunology, Sapporo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 10 Month 23 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

Enrolling by invitation

Date of protocol fixation

2015 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 23 Day

Last modified on

2015 Year 10 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name