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

Primary Purpose

Breast Cancer, Lymphedema

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Lymphedema, Treatment, Massage, Randomized, DLT therapy, Quality of Life, Decongestive Therapy, Breast Cancer related Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cross Cancer Institute
  • Dr. Leon Richard Oncology Centre
  • Saint John Regional Hospital
  • Dr. H. Bliss Murphy Cancer Centre
  • Juravinski Cancer Centre
  • London Regional Cancer Centre
  • Thunder Bay Regional Health Science Centre, Regional Cancer Centre
  • Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)

Standard of Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measurement of arm function
Quality of life

Full Information

First Posted
September 12, 2005
Last Updated
October 9, 2012
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Breast Cancer Research Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT00201890
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Breast Cancer Research Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema
Keywords
Breast Cancer, Lymphedema, Treatment, Massage, Randomized, DLT therapy, Quality of Life, Decongestive Therapy, Breast Cancer related Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Procedure
Intervention Name(s)
Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1)
Other Intervention Name(s)
Elastic Compression Sleeeve and Glove (Arm 2)
Intervention Description
20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove
Primary Outcome Measure Information:
Title
Percent reduction in excess arm volume as calculated from circumferential arm measurements
Time Frame
at 6 weeks
Secondary Outcome Measure Information:
Title
Measurement of arm function
Time Frame
Midtreatment,6,12 24,52 weeks
Title
Quality of life
Time Frame
Midtreament, 6 12,24,52 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Dayes, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tim Whelan, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Julian, M. Math
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyn Kligman, RN
Organizational Affiliation
London Regional Cancer Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathy Pritchard, MD
Organizational Affiliation
Sunnybrook Regional Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Dr. Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Thunder Bay Regional Health Science Centre, Regional Cancer Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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