Trial Radar KI | ||
|---|---|---|
enums.trial_summary.trial_summary_welcome | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Zurück zur Suche
Memorial Sloan Kettering KrebszentrumA Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06144164 untersucht Prävention im Zusammenhang mit Lymphödem, Lymphödem Arm, Lymphödem des Oberarms, Brustkrebs, Brustkarzinom, Weiblicher Brustkrebs. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 16. November 2023. Es ist geplant, 285 Teilnehmer aufzunehmen. Durchgeführt von Memorial Sloan Kettering Krebszentrum wird der Abschluss für 16. März 2030 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 7. November 2025 aktualisiert.
Kurzbeschreibung
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
Offizieller Titel
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
Erkrankungen
LymphödemLymphödem ArmLymphödem des OberarmsBrustkrebsBrustkarzinomWeiblicher BrustkrebsWeitere Studien-IDs
- 23-303
NCT-Nummer
Studienbeginn (tatsächlich)
2023-11-16
Zuletzt aktualisiert
2025-11-07
Studienende (vorauss.)
2030-03-16
Geplante Rekrutierung
285
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
immediate lymphatic reconstruction
axillary lymph node dissection
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast cancer
breast carcinoma
female breast cancer
Memorial Sloan Kettering Cancer Center
23-303
axillary lymph node dissection
Lymphedema
Lymphedema Arm
Lymphedema of Upper Arm
Breast cancer
breast carcinoma
female breast cancer
Memorial Sloan Kettering Cancer Center
23-303
Primäres Ziel
Prävention
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellParticipants with Breast Cancer Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection. | Immediate Lymphatic Reconstruction Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection Volumetric ARM Measurements Volumetric arm measurements will occur at each in-person postoperative visit time points. Lymphatic Massage Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed Range of Motion Exercises Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed Compression Garment Use Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The difference between the baseline and postoperative arm volume measurement | The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema | Up to 24 months |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
- Female sex
- Diagnosis of breast cancer
- Ages 18 to 75 years
- Consented for unilateral ALND or for unilateral SLNB with possible ALND
- Male sex
- Does not speak English
- Does not fit into study garment
- Axillary recurrence
- History of ALND
- Requirement of bilateral ALND for the treatment of breast cancer
- Treatment with SLNB only
- Known anaphylactic allergy to ICG dye used in ILR
- Impaired decision-making capacity
Memorial Sloan Kettering Krebszentrum737 aktive klinische Studien zum ErkundenZentrale Studienkontakte
Kontakt: Michelle Coriddi, MD, 646-608-8042, [email protected]
Kontakt: Babak Mahrara, MD, 646-608-8085, [email protected]
7 Studienstandorte in 1 Ländern
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung
New York
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, 11725, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States
Michelle Coriddi, MD, Kontakt, 646-608-8042
Offene Rekrutierung