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Completed

NCT Number: NCT00201890

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

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.

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Key information

Conditions

Breast Cancer Breast Cancer Lymphedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)

Procedure

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

Other names: Elastic Compression Sleeeve and Glove (Arm 2)

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

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Canadian Breast Cancer Research Alliance

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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