Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201890
Status:
COMPLETED
Last Update Posted:
2012-10-10
First Post:
2005-09-12
Brief Title:
Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer DELTA STUDY
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
Official Title:
DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None