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

NCT00201890 | Completed Phase 3 DMC

• 1 other identifier: CBCRA- 013260
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 9

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.

Conditions

Breast Cancer; Lymphedema

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  at 6 weeks

Secondary Outcomes (2)

• Measurement of arm function

  Midtreatment,6,12 24,52 weeks

• Quality of life

  Midtreament, 6 12,24,52 weeks

Study Arms (2)

1

EXPERIMENTAL

Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)

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

2

NO INTERVENTION

Standard of Care

Interventions

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

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Canadian Breast Cancer Research Alliance: collaborator

Study Sites (9)

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2, Canada

Location

Dr. Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Thunder Bay Regional Health Science Centre, Regional Cancer Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema

Interventions

Gloves, Protective

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ian Dayes, MD

  Ontario Clinical Oncology Group (OCOG)

  STUDY DIRECTOR

• Tim Whelan, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jim Julian, M. Math

  McMaster University

  PRINCIPAL INVESTIGATOR

• Lyn Kligman, RN

  London Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

• Kathy Pritchard, MD

  Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2003
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

CA (9)