Breast CancerNCT00935714
Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms
A study testing Exercise in people with Breast Cancer and Lymphedema, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Jan 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral arm lymphedema as a result of breast cancer treatment
- completion of breast cancer treatments
- arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
- in the maintenance phase of lymphedema treatment
Who cannot join
- women with recurrent cancer
- intercurrent diseases affecting the swollen arm
- lack of understanding of the Hebrew language
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Jillian Bracha, RN
Ehud Sternberg, MD
About this study
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Exercise
- Keywords
- Arm, Lymphedema, Breast Cancer, Exercise, Breast Cancer related Lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema, Motor Activity, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Muscle Group | Active comparator | Exercise Receives: Other: Exercise |
| Sequence | Active comparator | Exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved arm volume measurement
Measured: Weekly for five weeks
Secondary outcomes (1)
Quality of Life
Measured: Weekly for 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010 (estimated)
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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935714
- Sponsor's protocol ID
- 0023-09-HYMC
- Status last verified
- Aug 2009
- First submitted
- 8 Jul 2009
- Last updated
- 19 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms
- ClinicalTrials.gov ID
- NCT00935714
- Acronym / sponsor ID
- 0023-09-HYMC
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Arm, Lymphedema, Breast Cancer, Exercise, Breast Cancer related Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (estimated)
- First posted
- 9 Jul 2009 (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.
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Group | Active comparator | Other: ExerciseExercise |
| Sequence | Active comparator | Other: ExerciseExercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral arm lymphedema as a result of breast cancer treatment
- completion of breast cancer treatments
- arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
- in the maintenance phase of lymphedema treatment
Key exclusion criteria (3 listed)
- women with recurrent cancer
- intercurrent diseases affecting the swollen arm
- lack of understanding of the Hebrew language
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 |
|---|---|---|
| Exercise | Other | Muscle Group |
| Exercise | Other | Sequence |
Primary outcome
Improved arm volume measurement
Time frame: Weekly for five weeks
1 secondary outcome
Quality of Life
Time frame: Weekly for 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Cancer and Lymphedema, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Aug 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jillian H Bracha, BSc (972-523784551, gillianb@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved arm volume measurement (time frame: Weekly for five weeks). It is what the study was designed to measure, not a finding.
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 19 Aug 2009.