Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"

Inclusion Criteria:

• Women with a histological diagnosis of breast cancer experiencing edema in theipsilateral arm such that there is a minimum 15% increase in arm volume over theopposite arm.

• Patients must have completed all primary and adjuvant treatments (surgery,chemotherapy, radiotherapy) prior to randomization. This is to ensure that schedulingdifficulties with daily treatments do not arise. Patients may be currently takingtamoxifen 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 excessvolume related to lymphedema.)

• Previous surgery involving nodal dissection or radiotherapy to other majornode-bearing areas in the body such as the mediastinum or pelvis. Disruption oflymphatic flow in these potentially alternate routes may be compromised by suchinterventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy).

• Previously undergone massage therapy for arm edema, or has used compression sleevewithin the last month.

• Serious non-malignant disease, such as renal or cardiac failure, which would precludedaily treatment and follow up.

• Patients for whom massage is contraindicated, such as those with untreated infectionsor thromboses in the affected arm.

• Unable to commence therapy within 7 days of randomization.

• Psychiatric or addictive disorders which preclude obtaining informed consent oradherence to the protocol.