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NCT00376597 · ClinicalTrials.gov registry record

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 clinical trial, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status

NCT00376597: Completed study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00376597 is a clinical trial that has completed, run by Alliance for Clinical Trials in Oncology. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00376597 has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status

Study 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.

Primary Outcome

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

Interventions

  • OTHER educational intervention
  • OTHER quality of life assessment
  • PROCEDURE Physical therapy

Trial Details

FieldValue
Start Date 2006-06
Est. Completion 2017-06-15

What the finished NCT00376597 record still lists

NCT00376597 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 0 conditions, and to 3 interventions - of which educational intervention is the first listed.

NCT00376597 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00376597 about?

NCT00376597 is a clinical study titled "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". 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). Lymphe...

What is the current status of trial NCT00376597?

This trial is currently completed. The study started on 2006-06. Estimated completion is 2017-06-15.

What interventions are being tested in trial NCT00376597?

The interventions under investigation include: educational intervention (OTHER), quality of life assessment (OTHER), Physical therapy (PROCEDURE).

Who is sponsoring clinical trial NCT00376597?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00376597, the US trial registry maintained by the National Library of Medicine. NCT00376597 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.