Breast CancerNCT01142141
Manual Therapy in Postoperative Breast Cancer
A study testing manual therapy, kinesiotherapy in people with Breast Cancer and Axillary Lymph Node Dissection, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Axillary Lymph Node Dissection, Shoulder Joint Limitation
- What is being tested?
- manual therapy, kinesiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgery of breast cancer at University of Campinas
- axillary lymph node dissection
- injury of shoulder range of motion
Who cannot join
- bilateral surgery
- previous radiotherapy
- bone metastasis in homolateral upper limb
- axillary web syndrome
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb.
- Being tested
- manual therapy, kinesiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy, kinesiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy, kinesiotherapy | Other | Not described Receives: Other: manual therapy, kinesiotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startAug 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142141
- Sponsor's protocol ID
- 095/2006
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2010
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy in Postoperative Breast Cancer
- ClinicalTrials.gov ID
- NCT01142141
- Acronym / sponsor ID
- 095/2006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual therapy, kinesiotherapy | Other | Other: manual therapy, kinesiotherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgery of breast cancer at University of Campinas
- axillary lymph node dissection
- injury of shoulder range of motion
Key exclusion criteria (4 listed)
- bilateral surgery
- previous radiotherapy
- bone metastasis in homolateral upper limb
- axillary web syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual therapy, kinesiotherapy | Other | Manual therapy, kinesiotherapy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy, kinesiotherapy in people with Breast Cancer and Axillary Lymph Node Dissection, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.