- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05213936
Afkøling af hovedbunden til kemoterapi-induceret alopeci hos patienter med farve
Hovedbundskøling til kemoterapi-induceret alopeci hos patienter med farve: en klinisk og mekanistisk undersøgelse
Formålet med denne undersøgelse er at evaluere hårstylingsteknikker, der sigter mod at øge effektiviteten af hovedbundskøling i forebyggelsen af kemoterapi-induceret alopeci, bestemme hovedbundens kølende effekt på vedvarende kemoterapi-induceret alopeci og belyse molekylære mekanismer og forudsigelige biomarkører forbundet med succes i hårbund. patienter med farvet hud, der modtager kemoterapi for brystkræft eller ikke-småcellet lungekræft.
Denne undersøgelse udføres, fordi tidligere undersøgelser har fundet, at afkøling af hovedbunden er yderst effektiv til at forhindre hårtab som følge af kemoterapi. Minoritetsrepræsentationen var dog stort set begrænset i afsluttede forsøg. En nylig undersøgelse viste, at hovedbundskøleanordninger er mindre effektive hos patienter med farvet hud, sandsynligvis fordi patienter med farvet hud har hår hovedsageligt er type 3 (krøllet) og 4 (knækket), som har tendens til at blive større, når de er våde og kan forstyrre med kølehætte til hovedbunden. Efterforskerne planlægger at teste to teknikker, der sigter mod at forbedre hovedbundens afkølingseffektivitet hos patienter med farvet hud gennem hårstylingmetoder, der minimerer hårvolumen for at øge kontakten mellem kølehætten og hovedbunden: 1) cornrows/fletninger/snoninger eller 2) vand/balsamemulsion på hår. Foreløbige data viser, at brystkræftpatienter med type 3 eller 4 hår får taxane kemoterapi og hovedbundskøling ved hjælp af disse teknikker til at forberede håret til en hovedbundskølehætte, der passer til alle erfarne hårkonservering. Derudover vil efterforskerne også vurdere vedvarende kemoterapi-induceret alopeci udfald og forekomst ved at følge patienter op til 6 måneder efter afsluttet behandling. Endelig er specifikke genekspressionsændringer i taxan-induceret kemoterapi-induceret alopeci in vitro blevet beskrevet tidligere. Forskerne vil teste hypotesen om, at hovedbundskøling reverserer sådanne ændringer i kemoterapi-induceret alopeci, vurdere for biomarkører, der forudsiger hovedbundens afkølingssucces, og undersøge vedvarende kemoterapi-inducerede alopeci-molekylære mekanismer ved hjælp af ikke-invasiv transkriptom-sekventering på plukkede hårfollikler.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Beth McLellan, MD
- Telefonnummer: (718) 862-8840
- E-mail: bmclella@montefiore.org
Undersøgelse Kontakt Backup
- Navn: Yana Kost, BA
- Telefonnummer: 240-383-6896
- E-mail: yana.kost@einsteinmed.org
Studiesteder
-
-
New York
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The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Montefiore Medical Center
-
Kontakt:
- Warner Robinson, DMD
- Telefonnummer: 786-385-7775
- E-mail: warrobinso@montefiore.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Alder > 18 år
- Hår type 3 (krøllet) eller type 4 (kinky)
- Diagnose af bryst- eller ikke-småcellet lungekræft (NSCLC) stadium I-III
Patienten vil starte >4 cyklusser af taxan-baseret kemoterapibehandling for helbredende hensigt efter indskrivning
en. Samtidig behandling med HER, cisplatin og cyclophosphamid er tilladt
- Eastern Cooperative Oncology Group (ECOG) 0-2: fuldt aktiv, restriktiv i fysisk anstrengende aktivitet, ambulant og i stand til selvpleje
Ekskluderingskriterier:
- Anden hårtype end 3 eller 4
- Brug af hårvæv eller extensions uden planer om at fjerne
- Diagnose af brystkræft eller NSCLC stadium IV
- Samtidig malignitet inklusive hæmatologiske maligniteter (dvs. leukæmi eller lymfom)
- Alopeci Fælles terminologikriterier for bivirkninger > grad 1 ved baseline
- Tidligere administration af kemoterapi eller administration af antracykliner (doxorubicin)
- Anamnese med migræne eller klyngehovedpine, anoreksi, svær anæmi, ukontrolleret diabetes, hepatitis, skjoldbruskkirteldysfunktion, kold nældefeber, kold agglutininsygdom, hovedbundsmetastaser
- Planlagt knoglemarvsablation kemoterapi eller kraniebestråling
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Afkøling af hovedbunden med frisure
Afkøling af hovedbunden med frisure (fletninger, snoninger, cornrows) for at minimere hårvolumen og øge hovedbundens kølende hætte til hovedbundskontakt
|
Håret vil blive forberedt i overensstemmelse hermed til monteringen af kølehætten baseret på hvilken tilgang patienten foretrækker: fletninger/kranser/snoninger
|
|
Eksperimentel: Hovedbund Køling med balsam og vandemulsion
Afkøling af hovedbunden efter belægning af hår med balsam og vandemulsion for at minimere hårvolumen og øge hovedbundens kølende hætte til hovedbund kontakt
|
Hår vil blive forberedt i overensstemmelse hermed til tilpasningen baseret på hvilken tilgang patienten foretrækker: eller balsam og vandemulsion til at belægge håret.
|
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Ingen indgriben: Ingen hovedbundskøling
Kontrol uden afkøling af hovedbunden
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Severity of chemotherapy-induced alopecia - hair count density
Tidsramme: 4 weeks after completion of chemotherapy, up to ~6 months total
|
Severity of chemotherapy-induced alopecia, or CIA, as determined by hair count density from trichoscopy will be assessed.
Hair count density (hair counts/cm^2) will be summarized by study arm and analyzed using a T-test.
|
4 weeks after completion of chemotherapy, up to ~6 months total
|
|
Severity of chemotherapy-induced alopecia - adverse events
Tidsramme: 4 weeks after the completion of chemotherapy, up to ~6 months total
|
Severity of CIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading.
Results will be summarized by study arm and analyzed Fisher's exact test.
|
4 weeks after the completion of chemotherapy, up to ~6 months total
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density
Tidsramme: 26 weeks after completion of chemotherapy, up to ~11 months total
|
Severity of PCIA, as determined by hair count density from trichoscopy will be assessed.
Hair count density (hair counts/cm^2) will be summarized by study arm and analyzed using a T-test.
|
26 weeks after completion of chemotherapy, up to ~11 months total
|
|
Severity of persistent chemotherapy-induced alopecia - adverse events
Tidsramme: 26 weeks after completion of chemotherapy, up to ~11 months total
|
Severity of PCIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading.
Results will be summarized by study arm and analyzed Fisher's exact test.
|
26 weeks after completion of chemotherapy, up to ~11 months total
|
|
Patient distress after treatment
Tidsramme: 4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy)
|
Patient distress after treatment will be assessed by the Chemotherapy-induced Alopecia Distress Scale (CADS) scale.
CADS is a 17-item self-report tool used to measure distress related to chemotherapy-induced hair loss across four domains: physical, emotional, activity, and relationship.
Participants rate experiences, difficulties, or distress due to hair loss using a 4-point Likert scale ranging from 1 ("Not at all") to 4 ("Very much"), yielding an overall scoring range of 17-68, such that higher CADS scores are associated with higher distress.
Results will be summarized by study arm using basic descriptive statistics.
|
4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia
Tidsramme: 26 weeks after completion of chemotherapy
|
Using a non-invasive method of plucked hair follicles, the investigators will interrogate patients' hair follicle transcriptome at 26 weeks after chemotherapy completion to clarify persistent chemotherapy-induced alopecia pathogenesis.
The investigators will also identify predictive markers for cooling success through transcriptome profiling on hair follicles before and after chemotherapy in intervention and control groups.
|
26 weeks after completion of chemotherapy
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Beth McLellan, MD, Montefiore Medical Center
Publikationer og nyttige links
Generelle publikationer
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- Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038.
- Kluger N, Jacot W, Frouin E, Rigau V, Poujol S, Dereure O, Guillot B, Romieu G, Bessis D. Permanent scalp alopecia related to breast cancer chemotherapy by sequential fluorouracil/epirubicin/cyclophosphamide (FEC) and docetaxel: a prospective study of 20 patients. Ann Oncol. 2012 Nov;23(11):2879-2884. doi: 10.1093/annonc/mds095. Epub 2012 May 9.
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- Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.
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- Marks DH, Okhovat JP, Hagigeorges D, Manatis-Lornell AJ, Isakoff SJ, Lacouture ME, Senna MM. The effect of scalp cooling on CIA-related quality of life in breast cancer patients: a systematic review. Breast Cancer Res Treat. 2019 Jun;175(2):267-276. doi: 10.1007/s10549-019-05169-0. Epub 2019 Feb 26.
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- Shin H, Jo SJ, Kim DH, Kwon O, Myung SK. Efficacy of interventions for prevention of chemotherapy-induced alopecia: a systematic review and meta-analysis. Int J Cancer. 2015 Mar 1;136(5):E442-54. doi: 10.1002/ijc.29115. Epub 2014 Aug 11.
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- Rice BA, Ver Hoeve ES, DeLuca AN, Esserman LJ, Rugo HS, Melisko ME. Registry study to assess hair loss prevention with the Penguin Cold Cap in breast cancer patients receiving chemotherapy. Breast Cancer Res Treat. 2018 Jan;167(1):117-122. doi: 10.1007/s10549-017-4506-z. Epub 2017 Sep 18.
- Bajpai J, Kagwade S, Chandrasekharan A, Dandekar S, Kanan S, Kembhavi Y, Ghosh J, Banavali SD, Gupta S. "Randomised controlled trial of scalp cooling for the prevention of chemotherapy induced alopecia". Breast. 2020 Feb;49:187-193. doi: 10.1016/j.breast.2019.12.004. Epub 2019 Dec 12.
- Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.
- Vasconcelos I, Wiesske A, Schoenegg W. Scalp cooling successfully prevents alopecia in breast cancer patients undergoing anthracycline/taxane-based chemotherapy. Breast. 2018 Aug;40:1-3. doi: 10.1016/j.breast.2018.04.012. Epub 2018 Apr 13.
- Schaffrin-Nabe D, Schmitz I, Josten-Nabe A, von Hehn U, Voigtmann R. The Influence of Various Parameters on the Success of Sensor-Controlled Scalp Cooling in Preventing Chemotherapy-Induced Alopecia. Oncol Res Treat. 2015;38(10):489-95. doi: 10.1159/000440636. Epub 2015 Sep 27.
- Mayo TT, Callender VD. The art of prevention: It's too tight-Loosen up and let your hair down. Int J Womens Dermatol. 2021 Jan 29;7(2):174-179. doi: 10.1016/j.ijwd.2021.01.019. eCollection 2021 Mar.
- Araoye EF, Stearns V, Aguh C. Considerations for the Use of Scalp Cooling Devices in Black Patients. J Clin Oncol. 2020 Oct 20;38(30):3575-3576. doi: 10.1200/JCO.20.02130. Epub 2020 Sep 8. No abstract available.
- Katz A. Scalp Cooling: The Prevention of Chemotherapy-Induced Alopecia . Clin J Oncol Nurs. 2017 Aug 1;21(4):413-415. doi: 10.1188/17.CJON.413-415.
- Komen MM, Smorenburg CH, van den Hurk CJ, Nortier JW. Factors influencing the effectiveness of scalp cooling in the prevention of chemotherapy-induced alopecia. Oncologist. 2013;18(7):885-91. doi: 10.1634/theoncologist.2012-0332. Epub 2013 May 6.
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Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-13614
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