UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001143 |
|---|---|
| Receipt number | R000001387 |
| Scientific Title | Efficacy of shoulder exercise on loco regional complications in women undergoing radiotherapy for breast cancer: a controlled clinical trial |
| Date of disclosure of the study information | 2008/04/30 |
| Last modified on | 2008/04/30 23:08:53 |
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Basic information
Public title
Efficacy of shoulder exercise on loco regional complications in women undergoing radiotherapy for breast cancer: a controlled clinical trial
Acronym
Shoulder exercise for women undergoing radiotherapy for breast cancer
Scientific Title
Efficacy of shoulder exercise on loco regional complications in women undergoing radiotherapy for breast cancer: a controlled clinical trial
Scientific Title:Acronym
Shoulder exercise for women undergoing radiotherapy for breast cancer
Region
| South America |
Condition
Condition
Women submitted to breast surgery for breast cancer and had taken part of the post surgery rehabilitation program
Classification by specialty
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of shoulder exercise on prevention of physical complications in patients after breast cancer surgery and undergoing radiotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise improves the shoulder motion and minimize the occurrence of scar adherence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Women performed supervised exercises during RT (45 minutes, three times a week).The physiotherapy technique used was kinesiotherapy, composed of 19 exercises including flexion, extension, abduction, adduction, as well as internal and external rotation movements of upper limbs.
Interventions/Control_2
Received a manual containing instructions about arm care and routine activities
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Submitted to breast surgery for breast cancer
2. Taking part of the post surgery rehabilitation program
3. Functional ROM of the shoulder
Key exclusion criteria
1. Radiotherapy prior to surgery
2. Lymphedema of the upper limb and/or limitation in shoulder ROM prior to RT
3. Medical contraindication for physical exercise
4. Bilateral surgery
5. Local recurrence
Target sample size
69
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariana Maia Freire de Oliveira |
Organization
Universidade Estadual de Campinas – UNICAMP
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Caixa Postal: 6081
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Universidade Estadual de Campinas – UNICAMP
Division name
Department of Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Obstetrics and Gynecology, School of Medicine, Universidade Estadual de Campinas; UNICAMP, Sao Paulo, Brazil
Institute
Department
Personal name
Funding Source
Organization
CAPES - Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2005 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 30 | Day |
Last modified on
| 2008 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001387
