Lymphedema Clinical Trial
Official title:
PHASE I - II STUDY OF PRONE ACCELERATED BREAST AND NODAL IMRT(Intensity-Modulated Radiation Therapy)
Following consent, patients will receive 15 fractions of radiotherapy to the affected breast and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique: one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after completion of radiotherapy. All patients will be followed for toxicity and outcome (local and systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL at baseline, week 3, day 45-60 and 2-yr follow-ups.
A recent Cochrane Collaboration Intervention Review has addressed the effects of altered fractionation size on women with early breast cancer who have undergone breast conservation surgery. Analysis of two prospective randomized trials that included 2644 women, selected based on tumor size less than five cm, negative pathological margin of excision and negative lymph nodes. No difference in clinical outcome was detected. The conclusion of the review is that the use of unconventional fractionation regimens (greater than 2 Gy per fraction) does not affect breast appearance or toxicity, and does not seem to affect local recurrence or five years survival rates. After breast surgery and an adequate axillary dissection (i.e., at least 8 nodes retrieved in the axillary dissection specimen from level I and II) it is possible to identify patients with 1 - 5 positive nodes who require radiotherapy to both the indexed breast/chest wall and the draining nodal stations that the surgeon did not include in the traditional level I - II axillary dissection, i.e., level III and supraclavicular stations. We are proposing to test a new technique that extends prone set up to also include these lymph node regions. Limiting treatment to the supraclavicular fossa and level III axilla in patients with an adequately dissected axilla is supported by several published studies. Regional nodal recurrences are rare (occurring in 1 - 5%) in patients with early stage invasive breast cancer who have undergone breast conserving therapy. Several institutions choose to treat only the level III axilla and supraclavicular nodal stations in patients who have undergone surgical treatment of level I/II axilla. This technique was documented recently by Liengsawangwong, who utilized CT-delineated nodal stations to improve target coverage of SCV (Supra-Clavicular) and level III axillary nodes in patients who had undergone axillary level I/II dissection and were found to have positive lymph nodes. ;
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 |
NCT06323200 -
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
|
||
Completed |
NCT02506530 -
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
|
N/A | |
Terminated |
NCT02020837 -
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
|
Early Phase 1 | |
Completed |
NCT02253186 -
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
|
N/A | |
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 |
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 | |
Recruiting |
NCT06041958 -
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
|
N/A |