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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

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 257 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Notable

    Phase: Phase 3 to Not specified

    Enrollment target: 568 to not stated; Site details revised at 2 of 76 sites

    Study Status, Study Design, Contacts/Locations, IPDSharing, Referencesv257

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Study completion date changed from estimate of Dec 2018 to Jun 15, 2017

    Study Statusv256

  3. Notable

    Results first posted: Oct 2, 2017

    Primary endpoint revised; Enrollment target: estimated 877 to confirmed 568; Completion date: Dec 2018; and 2 more

    Show all 6 changes in this update
    • Notable Results first posted: Oct 2, 2017
    • Notable Primary endpoint revised
      Show what changed
      Number of Participants Who Were Lymphedema-free incidence18 Months After Randomization
    • Minor Enrollment target: estimated 877 to confirmed 568
    • Minor Completion date: Dec 2018
    • Minor Secondary endpoints revised (4)
      Show what changed
      SeverityChange ofFrom lymphedemaBaseline asat assessed18 by changesMonths in armArm circumferenceCircumference at the siteSite of greatestGreatest differenceDifference Agreement betweenBetween patientsPatients' selfSelf-report of swellingSwelling and the extentExtent of circumferentialCircumferential measurementMeasurement differenceDifference betweenBetween the treatedTreated sideSide and the contralateralContralateral armArm Health-related qualityQuality of lifeLife as assessedAssessed by FACT-B +4 scoreScore Adherence to lymphedemaLymphedema preventionPrevention exercisesExercises, lymphede [...] [...]
    • Minor Site details revised at 2 of 76 sites

    Study Status, Study Design, Outcome Measures, Contacts/Locations, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv255

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v254

  5. Minor

    Primary completion date: Jun 2015 to Nov 2015

    Study Statusv253

Show 45 earlier versions

  1. Notable

    Primary endpoint revised

    Eligibility criteria revised; Secondary endpoints: details revised at 4 of 4 entries

    Show what changed: Primary endpoints
    Lymphedema incidence, assessed by the percentage of women who remain free from the presence of lymphedema
    Show what changed: Eligibility criteria
    InclusionEligibility Criteria: Newly diagnosed with stage I-III cancer of the fe [...]

    Study Identification, Study Status, Outcome Measures, Eligibilityv252

  2. Notable

    Phase: Not applicable to Phase 3

    Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology; Enrollment target: 560 to 877; Primary completion date changed from estimate of Dec 2012 to Jun 2015; and 8 more

    Show all 12 changes in this update
    • Notable Phase: Not applicable to Phase 3
    • Notable Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology
    • Notable Enrollment target: 560 to 877
    • Notable Primary completion date changed from estimate of Dec 2012 to Jun 2015
    • Notable Primary endpoint revised
      Show what changed
      Lymphedema incidence, (assessed by the percentage of women who remain free from the presence of lymphedema for 18 months)
    • Minor Trial status: Recruiting to Active, Not Recruiting
    • Minor Interventions: assessment of therapy complications (Procedure), complementary or alternative medicine procedure (Procedure), educational intervention… to Physical therapy (Procedure), educational intervention (Other), quality of life assessment (Other)
    • Minor Eligibility criteria expanded, about 115 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: DiagnosisNewly 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 Newly* diagnosedPatients 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 t [...] disease which, in the opinion of the tr [...] [...]
    • Minor Secondary endpoints revised (4)
      Show what changed
      Severity of lymphedema as assessed by changes in arm circumference at the site of greatest difference Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score
    • Minor Study description shortened, about 135 words
      Show what changed
      OBJECTIVES: Primary DetermineI. To test, in a group randomized controlled trial, the efficacy of a comprehensivethis program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patientversus education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection. SecondaryII. CompareTo compare the severity of lymphedema, in terms of changes in arm circ [...] at the site of greatest difference as a continuous variable, inbetween patientsthe undergoing thesetwo interventions. Ass [...] [...]
    • Minor Study sites revised (76)
      Show what changed
      St. Vincent's Medical Center city: Moline, contacts: [{'name': 'Costas L. Constantinou, MD', 'phone': '563-359-9876', 'role': 'CONTACT'}], country: United States, geoPoint: {'lat': 41.5067, 'lon': -90.51513}, state: Illinois, status: RECRUITING, zip: 61265 city: Bettendorf, contacts: [{'name': 'Costas L. Constantinou, MD', 'phone': '563-359-9876', 'role': 'CONTACT'}], country: United States, geoPoint: {'lat': 41.52448, 'lon': -90.51569}, state: Iowa, status: RECRUITING, zip: 52722 AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv251

  3. Minor

    Study sites: 77 to 76

    Study Status, Contacts/Locationsv250

  4. Minor

    Study sites: 78 to 77

    Study Status, Contacts/Locationsv249

  5. Minor

    Study sites: 76 to 78

    Study Status, Contacts/Locationsv248

  6. Minor

    Study sites: 75 to 76

    Study Status, Contacts/Locationsv247

  7. Minor

    Study sites: 74 to 75

    Study Status, Contacts/Locationsv246

  8. Minor

    Study sites: 75 to 74

    Study Status, Contacts/Locationsv245

  9. Minor

    Study sites: 76 to 75

    Study Status, Contacts/Locationsv244

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v243

  11. Minor

    Study sites: 75 to 76

    Study Status, Contacts/Locationsv242

  12. Minor

    Study sites revised (75)

    Show what changed: Study sites
    St.Kaiser Mary'sPermanente RegionalTysons Cancer Center at St. Mary'sCorner Medical Center

    Study Status, Contacts/Locationsv241

  13. Minor

    Study Status

    Re-verified, no change to tracked fields

    v240

  14. Minor

    Study sites: 74 to 75

    Study Status, Contacts/Locationsv239

  15. Minor

    Study Status

    Re-verified, no change to tracked fields

    v238

  16. Minor

    Study sites: 76 to 74

    Study Status, Contacts/Locationsv237

  17. Minor

    Study sites: 75 to 76

    Study Status, Contacts/Locationsv236

  18. Minor

    Study sites: 77 to 75

    Study Status, Contacts/Locationsv235

  19. Minor

    Study Status

    Re-verified, no change to tracked fields

    v234

  20. Minor

    Site contacts updated at 1 of 77 sites

    Study Status, Contacts/Locationsv233

  21. Minor

    Study sites: 76 to 77

    Study Status, Contacts/Locationsv232

  22. Minor

    Study sites: 75 to 76

    Study Status, Contacts/Locationsv231

  23. Minor

    Study sites: 76 to 75

    Study Status, Contacts/Locationsv230

  24. Minor

    Study sites: 77 to 76

    Study Status, Contacts/Locationsv229

  25. Minor

    Site details revised at 1 of 77 sites

    Study Status, Contacts/Locationsv228

  26. Minor

    Study Status

    Re-verified, no change to tracked fields

    v227

  27. Minor

    Study sites: 76 to 77

    Study Status, Contacts/Locationsv226

  28. Minor

    Study sites: 71 to 76

    Study Status, Contacts/Locationsv225

  29. Minor

    Study sites: 51 to 71

    Study Status, Contacts/Locationsv224

  30. Minor

    Study sites: 50 to 51

    Study Status, Contacts/Locationsv223

  31. Minor

    Study sites: 49 to 50

    Study Status, Contacts/Locationsv222

  32. Minor

    Study sites: 50 to 49

    Study Status, Contacts/Locationsv221

  33. Minor

    Study sites: 69 to 50

    Study Status, Contacts/Locationsv220

  34. Minor

    Study sites: 77 to 69

    Study Status, Contacts/Locationsv219

  35. Minor

    Study sites: 78 to 77

    Study Status, Contacts/Locationsv218

  36. Minor

    Study sites: 77 to 78

    Study Status, Contacts/Locationsv217

  37. Minor

    Study sites: 73 to 77

    Study Status, Contacts/Locationsv216

  38. Minor

    Study sites: 75 to 73

    Study Status, Contacts/Locationsv215

  39. Minor

    Study sites: 76 to 75

    Study Status, Contacts/Locationsv214

  40. Minor

    Study sites: 77 to 76

    Study Status, Contacts/Locationsv213

  41. Minor

    Study sites: 78 to 77

    Study Status, Contacts/Locationsv212

  42. Minor

    Study sites: 79 to 78

    Study Status, Contacts/Locationsv211

  43. Minor

    Study sites: 78 to 79

    Study Status, Contacts/Locationsv210

  44. Minor

    Study sites: 77 to 78

    Study Status, Contacts/Locationsv209

  45. Minor

    Study sites: 76 to 77

    Study Status, Contacts/Locationsv208

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT00376597
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Lymphedema
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov