NCT00376597|CompletedPhase 3ResultsDMC

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

CALGB-70305CDR0000494652NCI-2009-00488U10CA037447

Study Type

interventional

Target

568

Locations

1 country

Sites

Timeline

RegisteredSep 2006

StartedJun 2006

CompletionJun 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

568

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2006

Longer than P75 for phase_3

Geographic Reach

1 country

76 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 years study duration

Study Start

First participant enrolled

June 1, 2006

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed

9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed

4 months until next milestone

Results Posted

Study results publicly available

October 2, 2017

Completed

Last Updated

February 7, 2019

Status Verified

January 1, 2019

Enrollment Period

9.4 years

First QC Date

September 13, 2006

Results QC Date

January 19, 2017

Last Update Submit

January 22, 2019

Conditions

Lymphedema

Keywords

lymphedemastage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

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
18 months

Secondary Outcomes (4)

Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
18 months
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm
18 months
Health-related Quality of Life as Assessed by FACT-B +4 Score
18 months
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength
from baseline up to 18 months

Study Arms (2)

Arm I (lymphedema education)

EXPERIMENTAL

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.

Other: quality of life assessmentOther: educational intervention

Arm II (lymphedema education, physical therapy)

EXPERIMENTAL

Description 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.

Other: quality of life assessmentOther: educational interventionProcedure: Physical therapy

Interventions

quality of life assessmentOTHER

Ancillary studies

Arm I (lymphedema education)Arm II (lymphedema education, physical therapy)

educational interventionOTHER

Receive lymphedema educational materials

Also known as: intervention, educational

Arm I (lymphedema education)Arm II (lymphedema education, physical therapy)

Physical therapyPROCEDURE

Complete physical therapy-focused intervention

Also known as: physiotherapy

Arm II (lymphedema education, physical therapy)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (76)

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, 94524-4110, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus