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DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer, Lymphedema

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Trial Information

DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent reduction in excess arm volume as calculated from circumferential arm measurements

Outcome Time Frame:

at 6 weeks

Safety Issue:


Principal Investigator

Ian Dayes, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ontario Clinical Oncology Group (OCOG)


Canada: Ethics Review Committee

Study ID:

CBCRA- 013260



Start Date:

March 2003

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • Lymphedema
  • Breast Cancer
  • Lymphedema
  • Treatment
  • Massage
  • Randomized
  • DLT therapy
  • Quality of Life
  • Decongestive Therapy
  • Breast Cancer related Lymphedema
  • Breast Neoplasms
  • Lymphedema