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

NCT00959985 | Terminated Results DMC

• 2 other identifiers: 08-308R01CA139118
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Breast Cancer

Keywords

compression sleeve; compression bandage

Outcome Measures

Primary Outcomes (6)

• To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment

  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.

  5 years

• 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

  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.

  5 years

• To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema

  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)

  5 years

• To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema

  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)

  5 years

• To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema

  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)

  5 years

• To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema

  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)

  5 years

Secondary Outcomes (2)

• 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

  5 years

• 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

  5 years

Study Arms (4)

Group 1A

NO INTERVENTION

Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Group 1B

ACTIVE COMPARATOR

Mild Lymphedema: Fitted for compression sleeve

Device: Compression Sleeve

Group 2A

ACTIVE COMPARATOR

Moderate lymphedema: Fitted with a compression sleeve

Device: Compression Sleeve

Group 2B

ACTIVE COMPARATOR

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

Device: Compression Sleeve; Device: Short-Stretch Compression Bandage

Interventions

Compression Sleeve DEVICE

Worn for a minimum of 12 hours per day

Group 1B; Group 2A; Group 2B

Short-Stretch Compression Bandage DEVICE

Worn overnight at least 5 nights of the week

Group 2B

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Alphonse G Taghian, MD PhD
• Organization: Massachusetts General Hospital

ataghian@partners.org

617-726-6050

Study Officials

• Alphonse G. Taghian, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Breast Service, Radiation Oncology

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 30, 2017
• Results First Posted: April 27, 2017

Record last verified: 2017-04

Locations

US (1)