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

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Record History

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

  1. Phase: Phase 3 to Not specified
    • Enrollment target: 568 to not stated
    • Site details revised at 2 of 76 sites
    v257
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2018 to Jun 15, 2017
    v256
  3. Results first posted: Oct 2, 2017v255 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 877 to confirmed 568
    • Study completion date: Dec 2018
    • Secondary endpoints revised (4)
    • Site details revised at 2 of 76 sites
  4. Re-verified, no change to tracked fieldsv254
  5. Primary completion date: Jun 2015 to Nov 2015v253
Show 45 earlier versionsHide 45 earlier versions
  1. Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 4 of 4 entries
    v252
  2. Phase: Not applicable to Phase 3v251 Show 11 more changesShow less
    • 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
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • 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)
    • Eligibility criteria expanded, about 115 words
    • Secondary endpoints revised (4)
    • Study description shortened, about 135 words
    • Study sites revised (76)
    • Study arms: 0 to 2
  3. Study sites: 77 to 76v250
  4. Study sites: 78 to 77v249
  5. Study sites: 76 to 78v248
  6. Study sites: 75 to 76v247
  7. Study sites: 74 to 75v246
  8. Study sites: 75 to 74v245
  9. Study sites: 76 to 75v244
  10. Re-verified, no change to tracked fieldsv243
  11. Study sites: 75 to 76v242
  12. Study sites revised (75)v241
  13. Re-verified, no change to tracked fieldsv240
  14. Study sites: 74 to 75v239
  15. Re-verified, no change to tracked fieldsv238
  16. Study sites: 76 to 74v237
  17. Study sites: 75 to 76v236
  18. Study sites: 77 to 75v235
  19. Re-verified, no change to tracked fieldsv234
  20. Site contacts updated at 1 of 77 sitesv233
  21. Study sites: 76 to 77v232
  22. Study sites: 75 to 76v231
  23. Study sites: 76 to 75v230
  24. Study sites: 77 to 76v229
  25. Site details revised at 1 of 77 sitesv228
  26. Re-verified, no change to tracked fieldsv227
  27. Study sites: 76 to 77v226
  28. Study sites: 71 to 76v225
  29. Study sites: 51 to 71v224
  30. Study sites: 50 to 51v223
  31. Study sites: 49 to 50v222
  32. Study sites: 50 to 49v221
  33. Study sites: 69 to 50v220
  34. Study sites: 77 to 69v219
  35. Study sites: 78 to 77v218
  36. Study sites: 77 to 78v217
  37. Study sites: 73 to 77v216
  38. Study sites: 75 to 73v215
  39. Study sites: 76 to 75v214
  40. Study sites: 77 to 76v213
  41. Study sites: 78 to 77v212
  42. Study sites: 79 to 78v211
  43. Study sites: 78 to 79v210
  44. Study sites: 77 to 78v209
  45. Study sites: 76 to 77v208
  • 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
(from sponsor)		 Lymphedema
Related terms Breast Neoplasms, Lymphedema
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov