Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
16. mars 2018 oppdatert av: Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems.
Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality.
Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear.
Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients.
Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS).
Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Shanghai
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Shanghai, Shanghai, Kina, 200011
- Shanghai Ninth People's Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
- Concurrent radiation and chemotherapy(platinum )
- Karnofsky score over 60
- No evidence of metastatic disease
- No significant cardiac, chest, gastrointestinal or renal morbidities
Exclusion Criteria:
- age <18 years
- ongoing artificial nutrition
- refusal
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: ONS group
Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)
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ONS group will receive Healing Elements ONS everyday during CRT
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Ingen inngripen: control group
Individualized dietary counseling during CRT
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Body weight(kg)change during concurrent chemotherapy
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
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every week during the course of radiotherapy, up to 6-7 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Disease-free survival
Tidsramme: 2 years
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From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.
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2 years
|
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Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
Tidsramme: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks
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every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
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Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
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Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
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every week during the course of radiotherapy, up to 6-7 weeks
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Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
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every week during the course of radiotherapy, up to 6-7 weeks
|
|
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Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
|
Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
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Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsramme: every week during the course of radiotherapy, up to 6-7 weeks
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every week during the course of radiotherapy, up to 6-7 weeks
|
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Serum albumin（g/L) change
Tidsramme: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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Serum prealbumin（mg/dL) change
Tidsramme: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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Serum transferrins（mg/dL）change
Tidsramme: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2014
Primær fullføring (Faktiske)
1. august 2016
Studiet fullført (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først innsendt
3. mai 2016
Først innsendt som oppfylte QC-kriteriene
15. mai 2016
Først lagt ut (Anslag)
18. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Faryngeale neoplasmer
- Otorhinolaryngologiske neoplasmer
- Neoplasmer i hode og nakke
- Nasofaryngeale sykdommer
- Faryngeale sykdommer
- Stomatognatiske sykdommer
- Otorhinolaryngologiske sykdommer
- Nasofaryngeale neoplasmer
- Karsinom
- Nasofaryngealt karsinom
Andre studie-ID-numre
- 1405135-4
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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