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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00959985
Recruitment Status : Terminated (low accrual)
First Posted : August 17, 2009
Results First Posted : April 27, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Results First Submitted Date  ICMJE January 4, 2017
Results First Posted Date  ICMJE April 27, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment [ Time Frame: 5 years ]
    Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.
  • To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment [ Time Frame: 5 years ]
    Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.
  • To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema [ Time Frame: 5 years ]
    Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)
  • To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema [ Time Frame: 5 years ]
    Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)
  • To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema [ Time Frame: 5 years ]
    Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)
  • To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema [ Time Frame: 5 years ]
    Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • To assess the efficacy of early intervention using compression garments for low volume lymphedema associated with breast cancer treatment. [ Time Frame: 2 years ]
  • 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: 2 years ]
  • To assess symptom clusters, treatment adherence, fear avoidance behavior, quality of life, and upper extremity function as it is associated with varying degrees of lymphedema. [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer [ Time Frame: 5 years ]
    Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review
  • To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer [ Time Frame: 5 years ]
    We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of >5%-<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • To identify risk factors associated with the onset of lymphedema that are both related and unrelated to treatment for breast cancer [ Time Frame: 2 years ]
  • To evaluate and understand the natural history of lymphedema during and after treatment for breast cancer [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer
Official Title  ICMJE Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial
Brief Summary Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.
Detailed Description
  • Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or Group 1B. Participants with moderate lymphedema will be randomized into either Group 2A or Group 2B.
  • All study participants will meet with a lymphedema physical therapist to review daily shoulder range of motion exercises to help minimize their arm swelling. They will be asked to record their range of motion exercises and activities in a study treatment journal. Participants will bring their journal to each study visit (every 4 weeks).
  • Group 1A will only be required to meet with the lymphedema physical therapist as described above.
  • Group 1B and Group 2A will be fitted with a compression sleeve at their first lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours per day.
  • Group 2B will also be fitted with a compression sleeve at their first lymphedema physical therapy visit and will wear the sleeve for a minimum of 12 hours per day. They will also be instructed to wear a short-stretch compression bandage that goes from the top of the hand to the armpit. They will be asked to wear this compression bandage during the night. The overnight compression bandage should be worn for at least 5 nights out of the week.
  • Participants will come to the clinic every 4 weeks. The following tests and procedures will be performed: height and weight measurements; review of any side effects; arm volume measurements for both arms; questionnaire.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphedema
  • Breast Cancer
Intervention  ICMJE
  • Device: Compression Sleeve
    Worn for a minimum of 12 hours per day
  • Device: Short-Stretch Compression Bandage
    Worn overnight at least 5 nights of the week
Study Arms  ICMJE
  • No Intervention: Group 1A
    Mild Lymphedema: Only required to meet with the lymphedema physical therapist
  • Active Comparator: Group 1B
    Mild Lymphedema: Fitted for compression sleeve
    Intervention: Device: Compression Sleeve
  • Active Comparator: Group 2A
    Moderate lymphedema: Fitted with a compression sleeve
    Intervention: Device: Compression Sleeve
  • Active Comparator: Group 2B
    Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage
    Interventions:
    • Device: Compression Sleeve
    • Device: Short-Stretch Compression Bandage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 14, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2009)
336
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
  • Participants must have undergone sentinel lymph node mapping or axillary dissection
  • Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
  • Age > 18 years
  • Life expectancy of greater than 1 year
  • Participants must have a Perometer measurement of 5% or greater volume difference (RVC) to qualify for randomization
  • Ability to understand and willingness to sign a written informed consent document
  • Willingness to comply with required follow up Perometer measurements and clinical visits

Exclusion Criteria:

  • Known metastatic disease or other locally advanced disease in the thoracic or cervical regions
  • Any patient who will not be returning routinely for follow-up
  • Known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of primary lymphedema
  • History of prior surgery or radiation to the head, neck, upper limb, or trunk
  • Evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion
  • Any patient who has bilateral lymph node mapping or dissection
  • Any patient with a current case of cellulitis
  • Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancer are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00959985
Other Study ID Numbers  ICMJE 08-308
R01CA139118 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Alphonse Taghian, MD, PhD, Massachusetts General Hospital
Original Responsible Party Alphonse G. Taghian, MD, PhD, Massachusetts General Hospital
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Alphonse G. Taghian, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP