UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062281 |
|---|---|
| Receipt number | R000071148 |
| Scientific Title | A randomized controlled trial to evaluate the efficacy of acupuncture and moxibustion in patients with taxane-induced peripheral neuropathy after curative treatment for breast cancer |
| Date of disclosure of the study information | 2026/08/22 |
| Last modified on | 2026/07/20 19:31:46 |
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Basic information
Public title
A randomized controlled trial to evaluate the efficacy of acupuncture and moxibustion in patients with taxane-induced peripheral neuropathy after curative treatment for breast cancer
Acronym
ACT-2 study
Scientific Title
A randomized controlled trial to evaluate the efficacy of acupuncture and moxibustion in patients with taxane-induced peripheral neuropathy after curative treatment for breast cancer
Scientific Title:Acronym
ACT-2 study
Region
| Japan |
Condition
Condition
chemotherapy-induced peripheral neuropathy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of acupuncture and moxibustion for chemotherapy-induced peripheral neuropathy in breast cancer survivors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in mean pain intensity from baseline to Week 16
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture and moxibustion
Interventions/Control_2
wait-list control
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 confirmed stage 1-3 breast cancer who have completed curative treatment.
2. Patients who are at least 3 months post-curative treatment, have no evidence of metastatic or recurrent disease, and are under observation without anticancer treatment (patients receiving postoperative endocrine therapy, anti-HER2 therapy, or molecularly targeted therapy are permitted).
3. Patients with CIPN caused by taxane-based chemotherapy.
4. Patients whose CIPN symptoms are rated as mild or greater on PRO-CTCAE Item 39a.
5. Patients with neuropathic pain attributable to CIPN and an average pain intensity score of 4 or higher on the NRS during the previous 24 hours.
6. Patients aged 18 years or older.
7. ECOG PS 0 or 1.
8. Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
1. Patients with peripheral neuropathy caused by factors other than taxane-based chemotherapy, such as severe edema, diabetes mellitus, postherpetic neuralgia, or vitamin B12 deficiency.
2. Patients with metastatic or recurrent disease at the time of enrollment.
3. Patients with fibromyalgia, inflammatory joint disease, or phantom limb pain.
4. Patients with psychiatric disorders, such as severe depression.
5. Patients with a history of acupuncture and moxibustion treatment for CIPN.
6. Patients receiving chemotherapy at the time of enrollment.
7. Patients with serious comorbidities.
8. Patients who are pregnant or breastfeeding.
9. Patients currently enrolled in a clinical trial or another study that may affect the results of this study.
10. Patients who are considered unsuitable for participation in this clinical trial by the investigator.
Target sample size
94
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
ncch-irb@ml.res.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
| 2026 | Year | 08 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071148
