UMIN-CTR Clinical Trial

Basic information
Public title	Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Acronym	Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Scientific Title	Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Scientific Title:Acronym	Effect of footbath on gastrointestinal cancer patients undergoing outpatient chemotherapy-randomized controlled trial-
Region	Japan

Condition
Condition	gastrointestinal cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the physical and psychological effects of footbaths on cancer patients undergoing outpatient chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	HADS of anxiety/depressive changes before and after chemotherapy in patients who received two outpatient chemotherapy treatments within a period of 3 to 4 weeks, and those who performed foot bath before chemotherapy and those who did not. , Evaluate with POMS.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Control group: Patients undergoing two outpatient chemotherapy within a period of 3-4 weeks Perform routine nursing care.
Interventions/Control_2	Control group: Three foot baths are given to patients receiving two outpatient chemotherapy within a period of 3-4 weeks.
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	45 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	atients with gastrointestinal cancer who have received outpatient chemotherapy between the ages of 45 and 75 and have been notified of cancer, and who have started outpatient chemotherapy within 1 year and are continuing Stage III-IV. Of these, two outpatient chemotherapy sessions are planned within a period of 3 to 4 weeks, and the physical symptoms are stable regardless of the presence or absence of recurrence, and Performance Status Grade 0 to 1, it is possible to maintain a sitting position for about 15 minutes. Those who have no wounds or skin lesions on their lower legs, can be immersed in hot water, have no mental illness, are not taking psychotropic drugs, and can have daily conversations and fill out questionnaires
Key exclusion criteria	Exclude patients with weekly outpatient chemotherapy, those who have an allergic reaction such as urticaria due to thermal stimulation, if the drug used in the chemotherapy may be affected by heat and the doctor's permission is not obtained.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Iwawaki
Organization	Kyoto Prefectural University of Medicine
Division name	Doctoral Program, Graduate School of Health and Nursing
Zip code	602-0857
Address	410 Nakagoryocho, Kamigyo-ku, Kyoto City, Kyoto Prefecture
TEL	075-251-5111
Email	iwawaki@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Sayuri Middle name Last name Okita
Organization	Kansai Medical University Hospital
Division name	Department of Nursing
Zip code	573-1191
Address	2-3-1, Shinmachi, Hirakata City, Osaka
TEL	072-804-0101
Homepage URL
Email	zayuzayu2000@yahoo.co.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine Doctoral Program, Graduate School of Health and Nursing
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine Doctoral Program, Graduate School of Health and Nursing
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	Kyoto Prefectural University of Medicine
Address	410 Nakagoryocho, Kamigyo-ku, Kyoto City, Kyoto Prefecture
Tel	0752515111
Email	iwawaki@koto.kpu-m.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	関西医科大学附属病院

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 31 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date	2020 Year 11 Month 30 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 09 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046905