UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051901 |
|---|---|
| Receipt number | R000059225 |
| Scientific Title | Safety and Efficacy of Acupuncture in Breast Cancer Survivors with Post-Mastectomy Pain Syndrome. |
| Date of disclosure of the study information | 2023/08/14 |
| Last modified on | 2023/08/15 14:00:02 |
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Basic information
Public title
Safety and Efficacy of Acupuncture in Breast Cancer Survivors with Post-Mastectomy Pain Syndrome.
Acronym
ABC-1 study
Scientific Title
Safety and Efficacy of Acupuncture in Breast Cancer Survivors with Post-Mastectomy Pain Syndrome.
Scientific Title:Acronym
ABC-1 study
Region
| Japan |
Condition
Condition
Post-Mastectomy Pain Syndrome
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of acupuncture in breast cancer survivors with post-mastectomy pain syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pain intensity (NRS) between baseline and week 16.
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture and moxibustion
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients with pathologically diagnosed Stage 1-3 breast cancer after radical surgery
2) Patients undergoing treatment-free follow-up at least 6 months after radical surgery without metastatic recurrence (patients on postoperative endocrine therapy or anti-HER2 therapy are included)
3) Postoperative average pain intensity (NRS) >= 4 over the past 24 hours in the chest, shoulder, or neck on the operated side
4) Age >= 18 years on the date of enrollment
5) ECOG PS 0 or 1 on the date of registration
6) Latest laboratory values within 28 days prior to enrollment (same day of the week 28 days prior to enrollment is acceptable) are
Neutrophils >= 1000/mcL, platelets >= 50,000/mcL
7) No change in pain medication* within 7 days prior to enrollment (same day of the week 7 days prior to enrollment is acceptable)
8) Patients who have given their free and voluntary consent in writing to participate in this study
Key exclusion criteria
1) Preoperative chest, shoulder, or neck pain on the operative side
2) Lymphedema in the upper extremity on the operative side
3) Bilateral chest, shoulder, or neck pain
4) Painful comorbidities such as fibromyalgia, inflammatory joint disease, etc.
5) Undergoing chemotherapy (excluding anti-HER2 therapy) or radiotherapy as of the date of registration
6) Has a psychiatric disorder such as severe depression (as determined by the attending physician)
7) Patients with serious complications (as determined by the attending physician)
8) Pregnant or lactating patients
9) Previous acupuncture treatment for PMPS
10) Patients currently enrolled in a clinical trial or a clinical trial affecting this study
11) Other patients deemed by the attending physician to be unsuitable for enrollment in the relevant clinical trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Ishiki |
Organization
National Cancer Center Hospital
Division name
Department of Palliative Medicine
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuoku, Tokyo, Japan
TEL
0335422511
hishiki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Ishiki |
Organization
National Cancer Center Hospital
Division name
Department of Palliative Medicine
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
Homepage URL
hishiki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Meedical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of the National Cancer Center
Address
5-1-1, Tsukiji, Chuoku, Tokyo, Japan
Tel
0335422511
hishiki@ncc.go.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 | 08 | Month | 14 | 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 | 07 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059225
