Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
16 mars 2018 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Shanghai
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Shanghai, Shanghai, Kina, 200011
- Shanghai Ninth People's Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: control group
Individualized dietary counseling during CRT
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Body weight(kg)change during concurrent chemotherapy
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Disease-free survival
Tidsram: 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
Tidsram: every 2 weeks during the course of radiotherapy, up to 6-7 weeks
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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
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Tidsram: 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
Tidsram: 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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Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsram: 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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|
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Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
Tidsram: 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
Tidsram: 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
Tidsram: 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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Serum albumin（g/L) change
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
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Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2014
Primärt slutförande (Faktisk)
1 augusti 2016
Avslutad studie (Faktisk)
1 januari 2018
Studieregistreringsdatum
Först inskickad
3 maj 2016
Först inskickad som uppfyllde QC-kriterierna
15 maj 2016
Första postat (Uppskatta)
18 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 mars 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 mars 2018
Senast verifierad
1 mars 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Faryngeala neoplasmer
- Otorhinolaryngologiska neoplasmer
- Neoplasmer i huvud och hals
- Nasofaryngeala sjukdomar
- Faryngeala sjukdomar
- Stomatogena sjukdomar
- Otorhinolaryngologiska sjukdomar
- Nasofaryngeala neoplasmer
- Carcinom
- Nasofaryngealt karcinom
Andra studie-ID-nummer
- 1405135-4
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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