Klinische Studien Radar

Name: Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)
Creator: Memorial Sloan Kettering Cancer Center
Published: 2025-04-08
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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Trial Radar KI Studienteilnehmer oder Patient Betreuer des Patienten Gesundheitsprofi Biotechnologieprofi Biotechnologieinvestor Forscher Sonstiges
	Die klinische Studie NCT06915116 für KREBS, Period Problem ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.

Eine Studie entspricht den Filterkriterien

Kartenansicht

Acupuncture for People Experiencing Period Loss Due to Chemotherapy Phase 2 60

Offene Rekrutierung

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 NCT06915116 untersucht Behandlung im Zusammenhang mit KREBS, Period Problem. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 31. März 2025. Es ist geplant, 60 Teilnehmer aufzunehmen. Durchgeführt von Memorial Sloan Kettering Krebszentrum wird der Abschluss für 31. März 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. März 2026 aktualisiert.

Kurzbeschreibung

The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of l...Mehr anzeigen

Offizieller Titel

Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)

Erkrankungen

KREBSPeriod Problem

Weitere Studien-IDs

25-020

NCT-Nummer

NCT06915116

Studienbeginn (tatsächlich)

2025-03-31

Zuletzt aktualisiert

2026-03-06

Studienende (vorauss.)

2027-03-31

Geplante Rekrutierung

Studientyp

Interventionsstudie

PHASE

Phase 2

Status

Offene Rekrutierung

Stichwörter

Acupuncture
Stage I cancer
Stage II cancer
Stage III cancer
Period Loss Due to Chemotherapy

Primäres Ziel

Behandlung

Zuteilungsmethode

Randomisiert

Interventionsmodell

Parallel

Verblindung

Keine (offene Studie)

Studienarme/Interventionen

Teilnehmergruppe/Studienarm

Intervention/Behandlung

ExperimentellAcupuncture group

Participants in the acupuncture group will receive 12 acupuncture treatments over 12 weeks during the study.

Akupunktur

Acupuncture will be delivered by licensed experienced acupuncturists at MSK. The intervention includes 12 treatments of acupuncture over 12 weeks (i.e. one treatment a week) with a +/- 14-day window. This window applies to the 12-week treatment period rather than to individual visits. The minimum required time between each treatment is 48 hours. When patients experience menses recovery during the treatment period, th...Mehr anzeigen

Aktives VergleichspräparatWait-list Control (WLC)

Participants in the wait-list control group will be put on a wait-list and have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period. The 16-week waiting period will begin on the day that the WLC participant completes their baseline lab draw.

No Acupuncture

Will have the option to receive the same acupuncture treatment as the acupuncture group after a 16-week waiting period

Was misst die Studie?

Hauptergebnismessungen

Ergebnismessung	Beschreibung der Messung	Zeitrahmen
Enrollment rate	This is the proportion of patients who enroll in the study among those who are eligible and offered participation. Reason for not participating will be documented (e.g. time/commitment, not wanting to be randomized, does not want the study intervention).	1 year
Acupuncture treatment adherence rate.	adherence rate is the proportion of patients randomized to the Acupuncture arm who are treatment adherent, defined as completing 10 or more of the 12 acupuncture sessions.	up to 16 weeks

Nebenergebnismessungen

Ergebnismessung	Beschreibung der Messung	Zeitrahmen
Menses recovery	Upon the return of menstruation, participants will inform to their CRCs. The CRCs will then send them the Bleeding Diary which is a link provided through REDCap to record the date and characteristics of their menses. They will be required to fill out this link daily until the menstrual cycle concludes	1 year

Teilnahme-Assistent

Eignungskriterien

Zugelassene Altersgruppen

Kind, Erwachsene

Mindestalter

15 Years

Zugelassene Geschlechter

Weiblich

English speaking woman between the ages of 15 and 40
History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team
Premenopausal status with regular menstruation at the time of diagnosis by patient report
Completed cytotoxic chemotherapy within the past year
Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older
Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
Have reached menarche prior to therapy or during therapy for females between 15 and 17 years old
Patient reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.
Have been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy
Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC

Had been pregnant or lactating within 3 months prior to enrollment
History of hysterectomy or bilateral oophorectomy
Ongoing or planned radiation or surgery within 4 months from randomization
Use of acupuncture for menses recovery within 3 months of enrollment
Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period

Memorial Sloan Kettering Krebszentrum

Zentrale Studienkontakte

Kontakt: Jun Mao, MD, MSCE, 646-608-8553, [email protected]

Kontakt: William Tap, MD, 646-888-4163

7 Studienstandorte in 1 Ländern

Vereinigte Staaten

New Jersey

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States