UMIN-CTR Clinical Trial

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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029891