N/A
N=568
Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection
Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT00376597 ↗Enrolled (actual)
568
Serious AEs
—
Results posted
Oct 2017
Primary outcome: Primary: Number of Participants Who Were Lymphedema-free 18 Months After Randomization — 114; 135 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- quality of life assessment (Other); educational intervention (Other); Physical therapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Lymphedema-free 18 Months After Randomization |
114; 135 | — |
| SECONDARY Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference |
55.1; 46.6 | — |
| SECONDARY Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm |
353; 8; 2; 11; 0; 0 | — |
| SECONDARY Health-related Quality of Life as Assessed by FACT-B +4 Score |
1.4; 0.1 | — |
| SECONDARY Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength |
77; 108; 51; 66; 94; 49 | — |
Summary
This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery. A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.
Eligibility Criteria
Eligibility Criteria:
- Newly diagnosed with stage I-III cancer of the female breast
- No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer
- Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible
- Neoadjuvant therapy
- Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
- Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
- Patients receiving no neoadjuvant therapy are eligible
- May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study
- No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
- No diagnosed lymphedema
- In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
- Not currently homebound or dependent upon a walker or wheelchair for mobility
- Able to participate in a mild exercise program
- Willing to return to the study site for the duration of the study (18 months)
- Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required)
- Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation
Data sourced from ClinicalTrials.gov (NCT00376597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.