UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051335 |
|---|---|
| Receipt number | R000058564 |
| Scientific Title | Phenotyping of pain with breast cancer survivors: clinical application of pain phenotyping across disease (CAD) study |
| Date of disclosure of the study information | 2023/06/15 |
| Last modified on | 2025/02/26 06:47:52 |
* 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
Phenotyping of pain with breast cancer survivors: clinical application of pain phenotyping across disease (CAD) study
Acronym
Classification of chronic pain for breast cancer survivors.
Scientific Title
Phenotyping of pain with breast cancer survivors: clinical application of pain phenotyping across disease (CAD) study
Scientific Title:Acronym
Classification of chronic pain using the Grading system.
Region
| Japan |
Condition
Condition
Breast cancer survivors
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the proportion and characteristics of patients with pain modulation pain among breast cancer survivors using the Grading System.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity (Brief pain inventory: BPI intensity), Pain interference (BPI interference)
Key secondary outcomes
Pain location, quantitative sensory testing, central sensitization-related symptoms, psychological symptoms, QoL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
(1) More than 1 year after breast cancer surgery
(2) Completed chemotherapy at least 6 months before assessment
Key exclusion criteria
Patients with metastasis, recurrent or bilateral breast cancer, and specific pain-related symptoms (acute trauma, rheumatic diseases, history of orthopaedic surgery, severe osteoarthritis)
Target sample size
109
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishigami |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-053
Address
1-1 Gakuen-cho, Mihara, Hiroshima
TEL
0848-60-1120
tomon@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Manfuku |
Organization
Breast Care Sensyu Clinic
Division name
Department of Rehabilitation
Zip code
596-0076
Address
2-17-11 Noda-cho, Kishiwada-shi, Osaka
TEL
072-430-0811
Homepage URL
sunday_attinente@yahoo.co.jp
Sponsor or person
Institute
Breast care sensyu clinic
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
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
Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara, Hiroshima
Tel
0848-60-1120
tomon@pu-hiroshima.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | 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
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the proportion and characteristics of patients with pain modulation pain among breast cancer survivors using an international assessment system for pain modulation pain.
Management information
Registered date
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058564
