UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034498
Receipt number 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 2023/10/18 11:45:45

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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

Obstetrics 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 Naotake
Middle name
Last name Tsuda

Organization

Kurume University

Division name

Obstetrics and Gynecology

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka

TEL

0942-31-7573

Email

naotakehouston@gmail.com


Public contact

Name of contact person

1st name Kazuto
Middle name
Last name Tasaki

Organization

Kurume University

Division name

Obstetrics and Gynecology

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka

TEL

0942-31-7573

Homepage URL


Email

kazzvic@yahoo.co.jp


Sponsor or person

Institute

Department of Obstetrics and Gynecology
Kurume University

Institute

Department

Personal name



Funding Source

Organization

Department of Obstetrics and Gynecology
Kurume University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Clinical Rseaech Center, Kurume University Hospital

Address

67 Asahi-machi Kurume, Fukuoka

Tel

0942-31-7200

Email

i_rinri@kurume-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

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

20

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

No longer recruiting

Date of protocol fixation

2018 Year 09 Month 20 Day

Date of IRB

2018 Year 09 Month 18 Day

Anticipated trial start date

2018 Year 10 Month 15 Day

Last follow-up date

2020 Year 07 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

2018 Year 10 Month 15 Day

Last modified on

2023 Year 10 Month 18 Day



Link to view the page

Value
https://center6.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