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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034498
Receipt No. R000039335
Scientific Title Feasibility study of cancer rehabilitation during concurrent chemoradiation for cervical cancer
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/15

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Basic information
Public title Feasibility study of cancer rehabilitation during concurrent chemoradiation for cervical cancer
Acronym Cancer rehabilitation during concurrent chemoradiation for cervical cancer
Scientific Title Feasibility study of cancer rehabilitation during concurrent chemoradiation for cervical cancer
Scientific Title:Acronym Cancer rehabilitation during concurrent chemoradiation for cervical cancer
Region
Japan

Condition
Condition cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessment of feasibility of excersie therapy during concurrent chemoradiation therapy (CCRT)for cervical cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Implementation rate of rehabilitation
Key secondary outcomes safety
body function (muscle srength, body composition, lower limb circumference, balance ability, walking ability)
Change of quality of life and fatigue
Adverse event and treatment completion rate of CCRT
Identification of factors related to completion of rehabilitation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Perform stretching, strength training, balance practice, endurance training for 20 minutes 4 times a week. Weekends, holidays and the day of chemotherapy were excluded.
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
90 years-old >
Gender Female
Key inclusion criteria 1. Patients who got written consent.
2. Over 20 years old
3. Patients who recieve CCRT under hospitalization for the diagnosis of cervical cancer
Key exclusion criteria 1. PS 3,4
2. Patients who need assistance in walking
3. Patients who have difficulty understanding instruction by language
4. Patients with complications affecting walking
5. Patient who is difficult to fill in questionnaire
6. Restriction of rest by bone lesion, cases where evaluation cooperation can not be obtained due to remarkable pain
7. Blood findings: Hb 7.5 g/dL or less, Plt 20,000/uL or less, WBC 3,000/uL or less
8. Invasion of more than 50% of the bone cortex, bone erosion towards the center of the bone, metastatic findings of the long bone with 3 cm or more lesions of the femur
9. Cavity internal organs, blood vessels, compression of the spinal cord
10. Pain, dyspnea, exudate retention in the pleura, pericardium, retroperitoneum with movement restriction
11. Dysfunction of the central nervous system, disturbance of consciousness, hypercranial hypertension
12. hypokalemia, hyperkalemia, hyponatremia, hypernatremia, hypocalcemia, hypercalcemia
13. Orthostatic hypotension, hypertension of 160/100 mmHg or more
14. Tachycardia of 110/min or more, ventricular arrhythmia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichiro Kawano
Organization Kurume University
Division name Obstetrics and Gynecology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7573
Email kawano_kouichirou@kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouichiro Kawano
Organization Kurume University
Division name Obstetrics and Gynecology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942-31-7573
Homepage URL
Email kawano_kouichirou@kurume-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology
Kurume University
Institute
Department

Funding Source
Organization Department of Obstetrics and Gynecology
Kurume 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 久留米大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 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
2018 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 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
2018 Year 10 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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