Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05056207
Other study ID # 2017-0639
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 17, 2017
Est. completion date November 17, 2026

Study information

Verified date March 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.


Description:

Primary Objectives: - To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives: - To estimate the direct costs associated with the Lymphedema Screening Initiative - To determine the association of the Initiative on patient productivity - To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care - To determine patient understanding of lymphedema-associated symptoms - To determine patient self-reported compliance with treatments and measures to prevent lymphedema - To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 260
Est. completion date November 17, 2026
Est. primary completion date November 17, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: a Cohort A: - Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection - English speaker - Patients who participate in Cohort A will be eligible for enrollment in Cohort b Cohort I: - Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection - English speaker c Cohort II: - Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson - English speaker Exclusion Criteria: Inability to complete a self-administered questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cohort I (patients receiving annual lymphedema screening
patientns who previously underwent preoperative perometer lymphedema screening
Cohort II (patients followed intensively for lymphedema)
patients who have recently undergone ALND

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer. through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Completed NCT06067880 - Surgical Intervention and Lymphatic Diseases.
Active, not recruiting NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema N/A
Completed NCT02676752 - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed NCT02506530 - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema N/A
Completed NCT06323200 - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
Completed NCT02253186 - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema N/A
Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
Recruiting NCT01318785 - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications Phase 2
Enrolling by invitation NCT02375165 - Biomarkers for the Detection of Lymphatic Insufficiency
Completed NCT00852930 - Low Level Laser Treatment and Breast Cancer Related Lymphedema Phase 4
Completed NCT01112189 - Use of Stem Cells in Lymphedema Post Mastectomy Phase 1/Phase 2
Completed NCT02308488 - Study of Prone Accelerated Breast And Nodal IMRT N/A
Completed NCT00743314 - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer Early Phase 1
Recruiting NCT06237907 - Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
Suspended NCT05366699 - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy N/A
Completed NCT06249360 - Lymphatic System Reflux After Lymphatic Operation
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A

External Links