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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

A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00376597
Enrollment
Unknown
Registered
2006-09-15
Start date
2006-06-01
Completion date
2017-06-15
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

lymphedema, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Brief 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.

Detailed description

OBJECTIVES: I. To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. II. To compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions. III. To assess the agreement between patients' self-report of swelling (mild, moderate, and severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference. IV. To compare the health-related quality of life (Factional Assessment of Cancer Therapy-Breast \[FACT-B\]+4 score) between the two interventions. V. To characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months. ARM II: Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

Interventions

OTHERquality of life assessment

Ancillary studies

OTHEReducational intervention

Receive lymphedema educational materials

PROCEDUREPhysical therapy

Complete physical therapy-focused intervention

Sponsors

Alliance for Clinical Trials in Oncology
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Were Lymphedema-free 18 Months After Randomization18 monthsTo test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms

Secondary

MeasureTime frameDescription
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference18 monthsTo compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm18 monthsTo assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.
Health-related Quality of Life as Assessed by FACT-B +4 Score18 monthsTo compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strengthfrom baseline up to 18 monthsTo characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.

Countries

United States

Contacts

STUDY_CHAIRElectra D. Paskett, PhD

Ohio State University Comprehensive Cancer Center

Participant flow

Participants by arm

ArmCount
Arm I (Lymphedema Education)
Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
242
Arm II (Lymphedema Education, Physical Therapy)
Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
312
Total554

Baseline characteristics

CharacteristicArm I (Lymphedema Education)Arm II (Lymphedema Education, Physical Therapy)Total
Age, Continuous57.9 years
STANDARD_DEVIATION 11.4
57.5 years
STANDARD_DEVIATION 11.2
57.7 years
STANDARD_DEVIATION 11.3
Region of Enrollment
United States
242 participants312 participants554 participants
Sex: Female, Male
Female
242 Participants312 Participants554 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Number of Participants Who Were Lymphedema-free 18 Months After Randomization

To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms

Time frame: 18 months

Population: 554 patients completed treatment and were analyzed.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm I (Lymphedema Education)Number of Participants Who Were Lymphedema-free 18 Months After Randomization114 Participants
Arm II (Lymphedema Education, Physical Therapy)Number of Participants Who Were Lymphedema-free 18 Months After Randomization135 Participants
Secondary

Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength

To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.

Time frame: from baseline up to 18 months

Population: 236 patients were analyzed for this endpoint.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength6 months1%-74%108 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength6 monthsNot at all/never51 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength12 months>=75%66 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength12 months1%-74%94 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength12 monthsNot at all/never49 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength18 months>=75%67 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength18 months1%-74%92 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength18 monthsNot at all/never55 Participants
Arm I (Lymphedema Education)Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength6 months>=75%77 Participants
Secondary

Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm

To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.

Time frame: 18 months

Population: 368 patients filled out a self assessment of swelling and were analyzed. This includes all patients that filled out a self-report of swelling, the two arms are combined because this is a comparison of actual swelling against self reported swelling, not a comparison of interventions.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm<0.5in difference between armsSelf Report None/Mild Swelling353 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm<0.5in difference between armsSelf Report Moderate swelling8 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm<0.5in difference between armsSelft Report Severe swelling2 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm0.5in - 2in difference between armsSelf Report None/Mild Swelling11 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm0.5in - 2in difference between armsSelf Report Moderate swelling0 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm0.5in - 2in difference between armsSelft Report Severe swelling0 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm>= 2in difference between armsSelf Report None/Mild Swelling1 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm>= 2in difference between armsSelf Report Moderate swelling1 Participants
Arm I (Lymphedema Education)Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm>= 2in difference between armsSelft Report Severe swelling0 Participants
Secondary

Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference

To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.

Time frame: 18 months

Population: 402 patients were analyzed for this endpoint.

ArmMeasureValue (MEAN)Dispersion
Arm I (Lymphedema Education)Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference55.1 cubic cmStandard Deviation 333.3
Arm II (Lymphedema Education, Physical Therapy)Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference46.6 cubic cmStandard Deviation 417.2
Secondary

Health-related Quality of Life as Assessed by FACT-B +4 Score

To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.

Time frame: 18 months

Population: 326 patients were analyzed for this measurement.

ArmMeasureValue (MEAN)Dispersion
Arm I (Lymphedema Education)Health-related Quality of Life as Assessed by FACT-B +4 Score1.4 Units on a scaleStandard Deviation 8.6
Arm II (Lymphedema Education, Physical Therapy)Health-related Quality of Life as Assessed by FACT-B +4 Score0.1 Units on a scaleStandard Deviation 8.9

Source: ClinicalTrials.gov · Data processed: May 19, 2026