Breast CancerPhase 3NCT00201890
Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"
A Phase 3 study testing Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) in people with Breast Cancer and Lymphedema, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with 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?
- Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 9 sitesCanada
- Study dates
- Mar 2003to Feb 2010
- Phase
- Phase 3
- 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
- Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm.
- Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. This is to ensure that scheduling difficulties with daily treatments do not arise. Patients may be currently taking tamoxifen or similar hormonal treatment.
Who cannot join
- Clinical or radiological evidence of active disease, either local or metastatic.
- History of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (Edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
- Previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. Disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy).
- Previously undergone massage therapy for arm edema, or has used compression sleeve within the last month.
- Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up.
- Patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm.
- Unable to commence therapy within 7 days of randomization.
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Regional Cancer Centre
London, Ontario, N6A 4L6
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Thunder Bay Regional Health Science Centre, Regional Cancer Centre
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with lymphedema.
This is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage.
Duration: One year after the last patient is randomized.
Read the detailed description
Randomized patients receive either standard of care or standard of care plus DLT (five massage sessions per week for 4 consecutive weeks). Primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. There is an extended follow-up of one year.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
- Keywords
- Breast Cancer, Lymphedema, Treatment, Massage, Randomized, DLT therapy, Quality of Life, Decongestive Therapy, Breast Cancer related Lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)Procedure or surgery
Also called Elastic Compression Sleeeve and Glove (Arm 2)
20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy) Receives: Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) |
| 2 | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in excess arm volume as calculated from circumferential arm measurements
Measured: at 6 weeks
Secondary outcomes (2)
Measurement of arm function
Measured: Midtreatment,6,12 24,52 weeks
Quality of life
Measured: Midtreament, 6 12,24,52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionFeb 2009
- Study completionFeb 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Research Alliance
- Responsible party
- Sponsor
- Investigators
- Ian Dayes, MD, Study director, Ontario Clinical Oncology Group (OCOG)Tim Whelan, MD, Principal investigator, McMaster UniversityJim Julian, M. Math, Principal investigator, McMaster UniversityLyn Kligman, RN, Principal investigator, London Regional Cancer CentreKathy Pritchard, MD, Principal investigator, Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201890
- Sponsor's protocol ID
- CBCRA- 013260
- Status last verified
- Oct 2012
- First submitted
- 12 Sep 2005
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00201890
- Acronym / sponsor ID
- CBCRA- 013260
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Breast Cancer, Lymphedema, Treatment, Massage, Randomized, DLT therapy, Quality of Life, Decongestive Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Breast Cancer Research Alliance
- Study start
- Mar 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with lymphedema.
This is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage.
Duration: One year after the last patient is randomized.
Detailed description
Randomized patients receive either standard of care or standard of care plus DLT (five massage sessions per week for 4 consecutive weeks). Primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. There is an extended follow-up of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy) |
| 2 | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm.
- Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. This is to ensure that scheduling difficulties with daily treatments do not arise. Patients may be currently taking tamoxifen or similar hormonal treatment.
Key exclusion criteria (8 listed)
- Clinical or radiological evidence of active disease, either local or metastatic.
- History of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (Edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
- Previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. Disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy).
- Previously undergone massage therapy for arm edema, or has used compression sleeve within the last month.
- Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up.
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 |
|---|---|---|
| Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)Also: Elastic Compression Sleeeve and Glove (Arm 2)20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove | Procedure or surgery | 1 |
Primary outcome
Percent reduction in excess arm volume as calculated from circumferential arm measurements
Time frame: at 6 weeks
2 secondary outcomes
Measurement of arm function
Time frame: Midtreatment,6,12 24,52 weeks
Quality of life
Time frame: Midtreament, 6 12,24,52 weeks
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 10 Oct 2012.
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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.
Ian Dayes, MD study director
Ontario Clinical Oncology Group (OCOG)
Tim Whelan, MD principal investigator
McMaster University
Jim Julian, M. Math principal investigator
McMaster University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) in people with Breast Cancer and Lymphedema, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
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 2 inclusion and 8 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 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Percent reduction in excess arm volume as calculated from circumferential arm measurements (time frame: at 6 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 10 Oct 2012.