UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009097 |
|---|---|
| Receipt number | R000010670 |
| Scientific Title | Effects of continuous traditional Japanese massage therapy (Anma therapy) for cancer survivors: a randomized controlled trial |
| Date of disclosure of the study information | 2012/10/12 |
| Last modified on | 2014/12/22 18:37:42 |
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Basic information
Public title
Effects of continuous traditional Japanese massage therapy (Anma therapy) for cancer survivors: a randomized controlled trial
Acronym
RCT of Anma massage therapy for cancer survivors
Scientific Title
Effects of continuous traditional Japanese massage therapy (Anma therapy) for cancer survivors: a randomized controlled trial
Scientific Title:Acronym
RCT of Anma massage therapy for cancer survivors
Region
| Japan |
Condition
Condition
Cancer survivors histologically confirmed to have had uterine cervical, endometrial, ovarian, fallopian tube, or peritoneal cancer in the past but with no recurrence for more than three years since receiving standard medical treatment.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of continuous traditional Japanese massage therapy (Anma therapy) for cancer survivors. Three following research questions are examined: If cancer survivors receive Anma therapy sessions continuously:
i) Are their subjective physical symptoms alleviated after cancer treatment?
ii) Are their subjective psychological symptoms alleviated after cancer treatment?
iii) Is their health-related quality of life improved?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint is change in the severity of subjective symptoms assessed using a visual analogue scale (VAS). VAS assessments are completed before and after the first intervention session and at the end of a continuous two-month period of intervention sessions.
Key secondary outcomes
Scores for the Japanese versions of the Hospital Anxiety Depression Scale (HADS), European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30), and the Mental Adjustment to Cancer (MAC Scale). In addition, measurements of oxidative stress in urine (8-hydroxydeoxyguanosine [8-OH-dG] etc.), salivary cortisol, chromogranin A, and secretory immunoglobulin A (s-IgA).
Self-reported questionnaire and urine sample testing are conducted before the first intervention session and at the end of the continuous two-month period of intervention sessions. Salivary samples are also collected before and after the first intervention session and at the end of a continuous two-month period of intervention sessions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Anma massage group receiving a 40-minute Anma massage session weekly over a two-month intervention period (total of eight Anma massage sessions).
Interventions/Control_2
Control group being followed by medical doctors and no Anma massage sessions.
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
Female cancer survivor histologically confirmed to have uterine cervical, endometrial, ovarian, fallopian tube, or peritoneal cancer in the past but with no recurrence in more than three years since receipt of standard medical treatment, who is over 20 years of age at the time of registration to the study, and who is selected by her doctor to be eligible for the study.
Key exclusion criteria
Progressive infectious disease, receiving treatment for organ disease (e.g. heart, liver, kidney), cognitive disorder.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomi DONOYAMA |
Organization
Tsukuba University of Technology
Division name
Department of Health, Faculty of Health Sciences
Zip code
Address
4-12-7, Kasuga, Tsukuba, Ibaraki, JAPAN 305-8521
TEL
0298589631
donoyama@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi DONOYAMA |
Organization
Tsukuba University of Technology
Division name
Department of Health, Faculty of Health Sciences
Zip code
Address
4-12-7, Kasuga, Tsukuba, Ibaraki, JAPAN 305-8521
TEL
029-858-9631
Homepage URL
donoyama@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from the Ministry of Education Science and Culture of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Tsukuba University of Technology
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
筑波技術大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 12 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 12 | Day |
Last modified on
| 2014 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010670
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
