Clinical trial NCT00201890: Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"
Official title: DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lymphedema
Keywords: Breast Cancer
Lymphedema
Treatment
Massage
Randomized
DLT therapy
Quality of Life
Decongestive Therapy
Breast Cancer related Lymphedema
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Research Alliance
First posted: 2005-09-20
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent reduction in excess arm volume as calculated from circumferential arm measurements
timeFrame: at 6 weeks
Secondary outcomes:
measure: Measurement of arm function
timeFrame: Midtreatment,6,12 24,52 weeks
measure: Quality of life
timeFrame: Midtreament, 6 12,24,52 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Moncton
country: Canada
facility: Dr. Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Centre, Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Ian Dayes, MD
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Tim Whelan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jim Julian, M. Math
role: PRINCIPAL_INVESTIGATOR
affiliation: London Regional Cancer Centre
name: Lyn Kligman, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Regional Cancer Centre
name: Kathy Pritchard, MD
role: PRINCIPAL_INVESTIGATOR
References: