UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047261 |
|---|---|
| Receipt number | R000053902 |
| Scientific Title | Efficacy of Acupuncture and moxibustion Treatment for Opioid-Induced Constipation in Patients with Cancer Pain. An Open-Label, Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2023/09/27 13:48:14 |
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Basic information
Public title
Study on the efficacy of acupuncture and moxibustion treatment for opioid-induced constipation in cancer pain patients
Acronym
Acupuncture and moxibustion treatment for constipation in cancer patients
Scientific Title
Efficacy of Acupuncture and moxibustion Treatment for Opioid-Induced Constipation in Patients with Cancer Pain. An Open-Label, Randomized Controlled Trial
Scientific Title:Acronym
Acupuncture and moxibustion treatment for constipation in cancer patients (RCT)
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test whether acupuncture and moxibustion treatment for opioid-induced constipation in cancer pain patients can improve constipation symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Constipation assessment scale (CAS)
Key secondary outcomes
Visual Analogue Scale (VAS)
Support Team Assessment Schedule Japanese (STAS-J)
Drug Dose
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1. Early intervention group
The pace of treatment will be twice a week for 3 weeks (6 sessions in total).
The treatment will take place at the University Hospital's palliative care outpatient clinic and in the hospital ward, and treatment will be given on the patient's bed.
Moxibustion is performed using an electronic moxibustion device to avoid the problem of smoke. The moxibustion should be applied to the same acupuncture points for 20 to 30 minutes at a time.
Acupuncture and moxibustion therapy should be given in addition to the usual drug therapy. Other supportive therapies are optional.
An interim examination (including a 1-week washout period) will be conducted after 3 weeks of intervention.
Final examination will be conducted after a 3-week non-intervention period.
Interventions/Control_2
2. Late intervention group
The usual drug therapy will be maintained for 3 weeks after the initial examination, and acupuncture and moxibustion therapy will not be performed (non-intervention period).
After the 3-week interim examination (including a 1-week washout period), the same intervention as in the previous intervention group will be performed.
Final examination will be conducted after 3 weeks.
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
Male and Female
Key inclusion criteria
1) Standard pharmacotherapy based on the WHO method for the treatment of cancer pain is being implemented.
2) Opioid-induced constipation symptoms are present
3) Acupuncture treatment is indicated.
4) Must be at least 20 years old
Key exclusion criteria
1) Patients judged to have a high probability of complicated skin inflammation or infection (subjective judgment of the physician in charge is allowed).
2) Patients with an immediate and obvious life-threatening condition.
3) Other patients deemed inappropriate by the study physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kanae |
| Middle name | |
| Last name | Kanda |
Organization
Kagawa University
Division name
Department of Public Health, Faculty of Medicine
Zip code
761-0973
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL
0878912133
kanda.kanae@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Kanda |
Organization
Kagawa University
Division name
Department of Public Health, Faculty of Medicine
Zip code
761
Address
1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL
0878912133
Homepage URL
kanda.kanae@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University
Address
1750-1Ikenobe, Miki, Kita, Kagawa, Japan
Tel
0878912133
kanda.kanae@kagawa-u.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
香川大学医学部附属病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053902
