UMIN-CTR Clinical Trial

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

malignant tumor

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Michigan Hand Outcome Questionnaire

Key secondary outcomes

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

no

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

02

Day

URL releasing protocol

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

Publication of results

Published

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

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 related 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