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Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00959985
First received: August 14, 2009
Last updated: March 15, 2017
Last verified: March 2017
Results First Received: January 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Lymphedema
Breast Cancer
Interventions: Device: Compression Sleeve
Device: Short-Stretch Compression Bandage

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1A Mild Lymphedema: Only required to meet with the lymphedema physical therapist
Group 1B

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Group 2A

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Group 2B

Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Compression Sleeve: Worn for a minimum of 12 hours per day

Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week


Participant Flow:   Overall Study
    Group 1A   Group 1B   Group 2A   Group 2B
STARTED   8   7   4   4 
COMPLETED   8   7   4   4 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1A Mild Lymphedema: Only required to meet with the lymphedema physical therapist
Group 1B

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Group 2A

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Group 2B

Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Compression Sleeve: Worn for a minimum of 12 hours per day

Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week

Total Total of all reporting groups

Baseline Measures
   Group 1A   Group 1B   Group 2A   Group 2B   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   4   4   23 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  62.5%      5  71.4%      4 100.0%      3  75.0%      17  73.9% 
>=65 years      3  37.5%      2  28.6%      0   0.0%      1  25.0%      6  26.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      8 100.0%      7 100.0%      4 100.0%      4 100.0%      23 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
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1.  Primary:   To Assess the Efficacy of Early Intervention Using Compression Garments for Low Volume Lymphedema Associated With Breast Cancer Treatment.   [ Time Frame: 5 years ]

2.  Primary:   To Assess the Efficacy of Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment, as a Method for the Alleviation of Lymphedema.   [ Time Frame: 5 years ]

3.  Primary:   To Assess Symptoms Associated With Varying Degrees of Lymphedema   [ Time Frame: 5 years ]

4.  Primary:   To Assess Fear Avoidance Behavior as it Associated With Varying Degrees of Lymphedema   [ Time Frame: 5 years ]

5.  Primary:   To Assess Quality of Life as it Associated With Varying Degrees of Lymphedema   [ Time Frame: 5 years ]

6.  Primary:   To Assess Upper Extremity Function as it Associated With Varying Degrees of Lymphedema   [ Time Frame: 5 years ]

7.  Secondary:   To Identify Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer   [ Time Frame: 5 years ]

8.  Secondary:   To Evaluate and Understand the Natural History of Lymphedema During and After Treatment for Breast Cancer   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was terminated due to slow accrual and small number of subjects for whom data was collected (23 out of expected 334). Study did not reach statistical power to conduct detailed analysis, results should be interpreted with this in mind


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alphonse G Taghian, MD PhD
Organization: Massachusetts General Hospital
phone: 617-726-6050 ext 24369
e-mail: ataghian@partners.org



Responsible Party: Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00959985     History of Changes
Other Study ID Numbers: 08-308
R01CA139118 ( US NIH Grant/Contract Award Number )
Study First Received: August 14, 2009
Results First Received: January 4, 2017
Last Updated: March 15, 2017