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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009676
Receipt No. R000011349
Scientific Title The effects of preventive interventions for constipation during breast cancer chemotherapy: a pilot study
Date of disclosure of the study information 2012/12/31
Last modified on 2014/05/12

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Basic information
Public title The effects of preventive interventions for constipation during breast cancer chemotherapy: a pilot study
Acronym Constipation preventive efficacy study for breast cancer
Scientific Title The effects of preventive interventions for constipation during breast cancer chemotherapy: a pilot study
Scientific Title:Acronym Constipation preventive efficacy study for breast cancer
Region
Japan

Condition
Condition Constipation with breast cancer therapy
Classification by specialty
Breast surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify whether the instructions of the nonpharmacological constipation prevention method (massage, exercises, excretion method) bring effects for constipation with the breast cancer chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Constipation
(Score of Constipation assessment scale)
Key secondary outcomes defecation
use of laxative
QOL
mood and emotional state
sleep activity rhythm
Action

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 the instruction of the constipation prevention method (massage, exercises, excretion method)for one week on the chemotherapy day before.
Interventions/Control_2 the instruction of the constipation prevention method (massage, exercises, excretion method) on the next chemotherapy day.
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 Female
Key inclusion criteria all the following conditions
(1)Admit into the Kyoto University hospital for breast cancer treatment and receiving chemotherapy
(2)Control emesis by the 5-HT3 receptor antagonist which include Ondansetron, Granisetron, Tropisetron, Palonosetron, before chemotherapy.
(3)Performance Status 0 or 1
(4)able to defecate with normal digestive organ and trunk function
(5)Signed informed consent for this study
Key exclusion criteria (1)Difficult to accept the researcher by mental disorder, cognitive impairment or physical disability
(2)Constipation before chemotherapy; higher than CTCAEv4.0 Grade2 (Persistent symptoms with regular use of axatives or enemas; limiting instrumental ADL)
(3)Pregnant
(4)Have difficulty in active exercise in physician judgement
(5)Inappropriate for this study in physician judgement
(5)In the chemotherapy term, it is necessary to continue aperient or supplement except our prescription in physician judgement
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Mitani
Organization Kyoto university graduate school of medicine
Division name Clinical Cognitive Neuroscience
Zip code
Address 53, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Hanai
Organization Kyoto university graduate school of medicine
Division name Clinical Cognitive Neuroscience
Zip code
Address 53, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL 075-751-3944
Homepage URL
Email hanai.akiko.44w@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto university graduate school of medicine
Institute
Department

Funding Source
Organization Kyoto university graduate school of medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Cancer professional training base promotion plan

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 12 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 Completed
Date of protocol fixation
2012 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 10 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
2012 Year 12 Month 31 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011349

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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