UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009676 |
|---|---|
| Receipt number | 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 22:18:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hanai.akiko.44w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
