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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009097
Receipt No. 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

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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
Obsterics 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
Email 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
Email donoyama@k.tsukuba-tech.ac.jp

Sponsor
Institute Tsukuba University of Technology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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