UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029389
Receipt number R000029891
Scientific Title Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients
Date of disclosure of the study information 2017/10/02
Last modified on 2022/10/15 09:31:21

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Basic information

Public title

Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients

Acronym

Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients

Scientific Title

Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients

Scientific Title:Acronym

Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients

Region

Japan


Condition

Condition

malignant tumor

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Rehabilitation medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify whether improvement of upper extremity / finger function, ADL and QOL is allowed by performing hand exercise program on CIPN patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Michigan Hand Outcome Questionnaire

Key secondary outcomes

grip strength, pinch strength, dexterity, tactile threshold, VAS, FACT-Ntx, PCS, nerve conduction velocity study


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver Other

Interventions/Control_1

hand exercise program

Interventions/Control_2

not treatment

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

Cases of cancer chemotherapy being underway and exhibiting symptoms of hands after chemotherapy began.
Cases receiving a disease name notification.
Cases of CIPN diagnosed.

Key exclusion criteria

Cases with severe organ damage (liver failure, renal failure, acute heart failure etc).
Cases whose age at registration is under 20 years.
Cases in which clean room treatment is done.
Case which cognitive function is declining(Mini-Mental State Examination: MMSE with 23 or less cases).
Cases of a mental disorder such as depression or schizophrenia disease and a disorder exhibiting symptoms in upper limbs and fingers in the past.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yuta
Middle name
Last name Ikio

Organization

Japanese Red Cross Society Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Rehabilitation

Zip code

852-8511

Address

3-15 mori-mati, nagasaki-si, nagasaki-ken

TEL

095-847-1511

Email

y.ikoiko@gmail.com


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Ikio

Organization

Japanese Red Cross Society Nagasaki Genbaku Hospital

Division name

Department of Rehabilitation

Zip code

852-8511

Address

3-15 mori-mati, nagasaki-si, nagasaki-ken

TEL

095-847-1511

Homepage URL


Email

y.ikoiko@gmail.com


Sponsor or person

Institute

Japanese Red Cross Society Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name



Funding Source

Organization

no

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Graduate School of Biomedical Sciences

Address

1-12-4 sakamoto-mati, nagasaki-si, nagasaki-ken

Tel

095-819-7195

Email

gakujutu_kikaku@ml.nagasaki-u.ac.jp


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

2017 Year 10 Month 02 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35188584/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35188584/

Number of participants that the trial has enrolled

42

Results

In the ITT analysis, the decline in activities of daily living of MHQ was significantly suppressed in the intervention group as compared to the control group at T2. Similarly, in the as-treated analysis, the decline in activities of daily living of MHQ was significantly suppressed in the intervention group as compared to the control group at T2. Pain was also significantly improved in the intervention group as compared to the control group at T2.

Results date posted

2022 Year 10 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Baseline characteristics were similar between the groups. In the as-treated analysis, only age was significantly different; intervention group: 72 (66-89), control group: 63 (57-87).

Participant flow

A total of 341 patients were assessed for eligibility and 42 were randomly assigned to either the intervention group (n = 21) or control group (n = 21). Reasons for ineligibility included the following: (1) had and/or may develop symptoms such as pain and numbness in the upper extremity (n = 51), (2) had bone metastases (n = 8), (3) complained of pain unrelated to CIPN (n = 11), (4) had cognitive decline (n = 4), and (5) had a psychiatric disorder (n = 1). Patients were also excluded for reasons such as poor general health (n = 2), not informed a diagnosis of cancer (n = 1), lack of an observation period (n = 7), regularly performed exercise outside of the trial (n = 2), and did not agree to be included (n = 5). Before baseline assessment, two patients in the intervention group were excluded for uncontrolled pain, and one patient in the control group was excluded because of acute deterioration.

Adverse events

In both groups, one patient experienced acute deterioration and one patient experienced uncontrolled pain during the observation period from the baseline of this study. Two patients in the control group were newly started on medication for neuropathic pain; no such changes occurred in the intervention group. There were no adverse events from the intervention itself, which was carried out in this study.

Outcome measures

The primary outcome was upper extremity function as measured by the Michigan Hand Outcomes Questionnaire (MHQ) after two chemotherapy cycles (T2). Secondary outcomes were upper extremity function after one chemotherapy cycle (T1), and muscle strength, sensory function, manual dexterity, degree of symptoms, pain catastrophizing, and QOL at T1 and T2. Clinical and demographic information were obtained from the electronic medical records.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 01 Day

Date of IRB

2016 Year 10 Month 13 Day

Anticipated trial start date

2016 Year 12 Month 15 Day

Last follow-up date

2020 Year 12 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 10 Month 02 Day

Last modified on

2022 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029891


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name