- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00040911
Electroacupuncture in Treating Delayed Nausea and Vomiting in Patients Receiving Chemotherapy For Newly Diagnosed Childhood Sarcoma, Neuroblastoma, Nasopharyngeal Cancer, Germ Cell Tumors, or Hodgkin Lymphoma
A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
RATIONALE: Electroacupuncture may help to reduce or prevent delayed nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This randomized clinical trial is studying the effectiveness of electroacupuncture in treating delayed nausea and vomiting in patients who are receiving chemotherapy for newly diagnosed childhood sarcoma, neuroblastoma, nasopharyngeal cancer, germ cell tumors, or Hodgkin lymphoma.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the efficacy of electroacupuncture, in terms of reducing acute and delayed chemotherapy-induced nausea, in patients with newly diagnosed pediatric sarcoma, neuroblastoma, nasopharyngeal carcinoma, or germ cell tumors.
Secondary
- Determine the efficacy of this therapy, in terms of reducing delayed chemotherapy-induced emesis, in these patients.
- Determine the efficacy of this therapy, in terms of altering salivary cortisol levels and fasting serum glucose and insulin levels as stress parameters, in these patients.
- Determine the efficacy of this therapy, in terms of improving the quality of life, in these patients.
- Determine the efficacy of this therapy, in terms of reducing acute nausea and emesis, in these patients.
OUTLINE: This is a multicenter, randomized, double-blind study. Patients are stratified according to planned treatment with cisplatin-based chemotherapy (yes vs no) and gender. Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo electroacupuncture to specific acupuncture points on the arms and legs over 25 minutes twice daily on days 1 and 2 and then once daily on days 3-7 during week 1 of chemotherapy course 1 (9 acupuncture treatments total).
- Arm II: Patients undergo electroacupuncture to sham points on the arms and legs as in arm I.
Quality of life is assessed at baseline, on days 1 and 8 of each treatment course, and then after completion of the study.
PROJECTED ACCRUAL: A total of 65 patients (approximately 32 per arm) will be accrued for this study within 2.5-3 years.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Newly diagnosed malignancy of 1 of the following types:
- Pediatric sarcoma
- Neuroblastoma
- Nasopharyngeal carcinoma
- Germ cell tumor
- Hodgkin lymphoma
Meets 1 of the following criteria:
- Eligible for Children's Oncology Group (COG) protocol for sarcoma, neuroblastoma, or germ cell tumor
- Eligible for NCI Pediatric Oncology Branch (POB) protocol for sarcoma
- Following COG-approved standard treatment regimen for sarcoma, neuroblastoma, nasopharyngeal carcinoma, or germ cell tumor
- Enrolled on the POB natural history protocol 98-C-0037
- Planned treatment, according to COG or POB protocols, that includes a cisplatin- and/or doxorubicin-containing regimen for sarcoma, neuroblastoma, nasopharyngeal carcinoma, germ cell tumor, or Hodgkin lymphoma OR either a cyclophosphamide/ifosfamide-doxorubicin-containing or cyclophosphamide/dactinomycin-containing regimen for rhabdomyosarcoma
- No clinical or radiographic signs of spinal cord compression
PATIENT CHARACTERISTICS:
Age:
- 5 to 35
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 50,000/mm^3 (transfusion independent)
- No clotting disorders, including hemophilia
Hepatic:
- PT and PTT normal (within 10% of institution's upper limit of normal)
Renal:
- Not specified
Other:
- Not pregnant
- No casting of 1 or more extremities
- No other condition that would preclude access to acupuncture points
- No cognitive impairment
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior systemic chemotherapy
Endocrine therapy:
- More than 4 weeks since prior glucocorticoid therapy
- No concurrent glucocorticoid therapy
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior acupuncture
- No concurrent anticoagulants
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I (alternative medicine procedure)
Patients undergo electroacupuncture therapy to specific acupuncture points on the arms and legs over 25 minutes twice daily on days 1 and 2 and then once daily on days 3-7 during week 1 of chemotherapy course 1 (9 acupuncture treatments total).
|
Hjelpestudier
|
Sham-komparator: Arm II (alternative medicine procedure)
Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
|
Hjelpestudier
Undergo electroacupuncture therapy to sham points
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
Tidsramme: 7 days
|
A two-sample t-test will be used.
In the event the data are not normally distributed in one or both arms, a Wilcoxon rank sum test will be used.
|
7 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Tidsramme: Day 8
|
Day 8
|
|
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
Tidsramme: Day 1
|
It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.
|
Day 1
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Kara Kelly, MD, Herbert Irving Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- stadium III plateepitelkarsinom i nasopharynx
- stadium III lymfepitelom i nasofarynx
- stadium IV plateepitelkarsinom i nasopharynx
- stadium IV lymfepitheliom i nasofarynx
- stadium I plateepitelkarsinom i nasopharynx
- stadium II plateepitelkarsinom i nasopharynx
- lokalisert osteosarkom
- stadium III voksen Hodgkin lymfom
- stadium IV voksen Hodgkin lymfom
- spredt nevroblastom
- lokalisert inoperabelt nevroblastom
- stadium 4S nevroblastom
- regionalt nevroblastom
- stadium IV barndoms Hodgkin lymfom
- stadium III barndoms Hodgkin lymfom
- metastatisk Ewing-sarkom/perifer primitiv nevroektodermal svulst
- metastatisk osteosarkom
- stadium I voksen Hodgkin lymfom
- stadium II voksen Hodgkin lymfom
- stadium I barndoms Hodgkin lymfom
- stadium II barndoms Hodgkin lymfom
- kvalme og oppkast
- metastatisk bløtvevssarkom fra barndommen
- barndoms svulst i sentralnervesystemet
- barndom teratom
- ondartet testikkelcelletumor i barndommen
- barndoms maligne ovarie-kimcelletumor
- ekstragonadal kjønnscelletumor i barndommen
- tidligere ubehandlet rabdomyosarkom i barndommen
- ikke-metastatisk bløtvevssarkom fra barndommen
- lokalisert resektabelt nevroblastom
- lokalisert Ewing-sarkom/perifer primitiv nevroektodermal svulst
- stadium I lymfepitheliom i nasopharynx
- stadium II lymfepitheliom i nasopharynx
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Sykdommer i immunsystemet
- Neoplasmer, bindevev og mykt vev
- Neoplasmer etter histologisk type
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Tegn og symptomer, fordøyelseskanal
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, nervevev
- Neuroektodermale svulster, primitive
- Neuroektodermale svulster, primitive, perifere
- Neoplasmer
- Sarkom
- Lymfom
- Neoplasmer, kjønnsceller og embryonale
- Kvalme
- Oppkast
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Nevroblastom
Andre studie-ID-numre
- ACCL04C2
- NCCAM-02-AT-0172
- NCI-02-AT-0172 (Annen identifikator: NCI)
- COG-ACCL04C2 (Annen identifikator: Children's Oncology Group)
- CDR0000069419 (Annen identifikator: Clinical Trials.gov)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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