Know Cancer

or
forgot password

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Lymphedema, Breast Cancer

Thank you

Trial Information

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy of early intervention using compression garments for low volume lymphedema associated with breast cancer treatment.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Alphonse G. Taghian, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

08-308

NCT ID:

NCT00959985

Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Lymphedema
  • Breast Cancer
  • compression sleeve
  • compression bandage
  • Breast Neoplasms
  • Lymphedema

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617