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CompletedNCT00201890Updated Oct 10, 2012

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

A Phase 3 interventional study of Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) in Breast Cancer and Lymphedema, sponsored by Ontario Clinical Oncology Group (OCOG). Completed at 9 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-10.

Sponsored by Ontario Clinical Oncology Group (OCOG) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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.

02

Conditions studied

  • Breast Cancer
  • Lymphedema

Keywords

  • Breast Cancer
  • Lymphedema
  • Treatment
  • Massage
  • Randomized
  • DLT therapy
  • Quality of Life
  • Decongestive Therapy
  • Breast Cancer related Lymphedema
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 103 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Ontario Clinical Oncology Group (OCOG) is the lead sponsor of 56 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    1

    Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)

    Procedure: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)

  • No intervention
    2

    Standard of Care

Interventions

  • ProcedureLymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)

    20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove

    Also known as: Elastic Compression Sleeeve and Glove (Arm 2)

06

What researchers measure

Primary outcomes

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

    Time frame: at 6 weeks

Secondary outcomes

  1. Measurement of arm function

    Time frame: Midtreatment,6,12 24,52 weeks

  2. Quality of life

    Time frame: Midtreament, 6 12,24,52 weeks

07

Study locations

9 sites
  • Cross Cancer Institute
    Edmonton, Alberta T6G1Z2, Canada
  • Dr. Leon Richard Oncology Centre
    Moncton, New Brunswick E1C 8X3, Canada
  • Saint John Regional Hospital
    Saint John, New Brunswick E2L 4L2, Canada
  • Dr. H. Bliss Murphy Cancer Centre
    St. John's, Newfoundland and Labrador A1B 3V6, Canada
  • Juravinski Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
  • London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Thunder Bay Regional Health Science Centre, Regional Cancer Centre
    Thunder Bay, Ontario P7B 6V4, Canada
  • Sunnybrook Regional Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00201890
Lead sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Breast Cancer Research Alliance
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Mar 2003
Primary completion
Feb 2009
Completion
Feb 2010
Last update
Oct 10, 2012

Study contacts

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
Lyn Kligman, RN
principal investigator · London Regional Cancer Centre
Kathy Pritchard, MD
principal investigator · Sunnybrook Regional Cancer Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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