Assessment of the Nutritional Status of Children and Adolescents With Malignancies
2014年9月19日 更新者：University of Hohenheim
Assessment of the Nutritional Status of Children and Adolescents With Malignancies Aged Between 0-18, Based on BMI Percentiles and Standard Deviation Scores, at Diagnosis, During Treatment, and During Two Years Follow-up
The main objective of this study was the assessment of the nutritional status of children and adolescents aged between 0-18 with malignancies based on BMI percentiles and standard deviation scores, at diagnosis, during treatment and during a period of two years after the end of therapy.
調査の概要
状態
完了
条件
詳細な説明
Children and adolescents suffering from malignancies often show malnutrition. Malnutrition, defined as a deficiency or an excess of energy, is associated with an increased risk of comorbidities, reduced survival rates, higher relapse rates, and worse treatment response.
The present retrospective study assessed the nutritional status of children and adolescents, suffering from nine different kinds of cancer, based on BMI percentiles and standard deviation scores. Anthropometric data were recorded from clinical charts and an assessment of the nutritional status was made at the beginning of treatment, during the course of therapy and during a follow-up period of two years. The influence of treatment-related characteristics, the duration of therapy, and the occurrence of a relapse or progress during therapy on the nutritional status were examined.
研究の種類
観察的
入学 (実際)
135
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳未満 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Children and adolescents, treated for one of the following diseases: lymphoma, germ cell tumor, nephroblastoma, soft tissue sarcoma, neuroblastoma, Ewing sarcoma, brain tumor, or acute lymphoblastic leukemia (ALL)/acute myeloid leukemia (AML)
説明
Inclusion Criteria:
- children and adolescents treated at the Olgahospital Stuttgart for one of the nine different cancer types
- treated according to a study protocol of the Society of Pediatric Oncology and Hematology (GPOH), with modifications only allowed within the therapeutic protocol
- time period between diagnosis and start of treatment less than 28 days
- age younger than 18
Exclusion Criteria:
- severe underlying disease, which exerts a strong influence on weight and/or height
- patients whose clinical record does not state any weight and/or height
- diseases which are not considered as malignant because of the state or biology
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 時間の展望：回顧
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nutritional status at diagnosis
時間枠：Within the month of diagnosis
|
To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile (Body Mass Index percentile) and the BMI-SDS (Body Mass Index-Standard Deviation Score)
|
Within the month of diagnosis
|
|
Change in nutritional status during treatment
時間枠：Every month during the treatment period (average treatment period 11 months)
|
To assess the nutritional status height and weight were recorded from patient charts to calculate the BMI percentile and the BMI-SDS
|
Every month during the treatment period (average treatment period 11 months)
|
|
Change in nutritional status during follow-up
時間枠：Once in a period of three months during two years follow-up
|
To assess the nutritional status height and weight were recorded from patient chart to calculate the BMI percentile and the BMI-SDS
|
Once in a period of three months during two years follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical picture
時間枠：Within the month of diagnosis
|
Kind of cancer (lymphoma, germ cell tumor, nephroblastoma, soft tissue sarcoma, neuroblastoma, Ewing sarcoma, brain tumor, acute lymphoblastic leukemia (ALL)/acute myeloid leukemia (AML)), recorded from patient chart
|
Within the month of diagnosis
|
|
Age (years)
時間枠：Within the month of diagnosis
|
Age in years, recorded from patient chart
|
Within the month of diagnosis
|
|
Treatment period (months)
時間枠：Patients were followed for the duration of their treatment period. Average treatment period 11 months
|
Time from start until the end of treatment, recorded from patient chart
|
Patients were followed for the duration of their treatment period. Average treatment period 11 months
|
|
Incidence of nutritional interventions
時間枠：Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)
|
Application of parenteral nutrition or gastric tube (yes/no), recorded from patient chart
|
Patients were followed for the incidence of a nutritional intervention within the treatment period (average treatment period 11 months)
|
|
Infection
時間枠：Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)
|
Occurence of an infection (yes/no), recorded from patient chart
|
Patients were followed for the occurence of an infection within the treatment period (average treatment period 11 months)
|
|
Fever
時間枠：Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)
|
Occurence of fever (yes/no), recorded from patient chart
|
Patients were followed for the occurence of fever within the treatment period (average treatment period 11 months)
|
|
Administration of antibiotics
時間枠：Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)
|
Administration of antibiotics (yes/no), recorded from patient chart
|
Patients were followed for the occurence of an administration of antibiotics within the treatment period (average treatment period 11 months)
|
|
Diarrhea
時間枠：Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)
|
Occurence of diarrhea (yes/no), recorded from patient chart
|
Patients were followed for the occurence of diarrhea within the treatment period (average treatment period 11 months)
|
|
Mucositis
時間枠：Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)
|
Occurence of mucositis (yes/no),recorded from patient chart
|
Patients were followed for the occurence of mucositis within the treatment period (average treatment period 11 months)
|
|
Nausea
時間枠：Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)
|
Occurence of nausea (yes/no), recorded from patient chart
|
Patients were followed for the occurence of nausea within the treatment period (average treatment period 11 months)
|
|
Constipation
時間枠：Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)
|
Occurence of constipation (yes/no), recorded from patient chart
|
Patients were followed for the occurence of constipation within the treatment period (average treatment period 11 months)
|
|
Relapse/Progress
時間枠：Patients were followed for the occurence of a relapse/progress within the treatment period (average treatment period 11 months) and follow-up (two years)
|
Occurence of a relapse/progress (yes/no), recorded from patient chart
|
Patients were followed for the occurence of a relapse/progress within the treatment period (average treatment period 11 months) and follow-up (two years)
|
|
Kind of treatment
時間枠：Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)
|
Kind of treatment (chemotherapy, operation, Radiation), recorded from Patient chart
|
Patients were followed for the kind of treatment they received wihin the treatment period (average treatment period 11 months)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年6月1日
一次修了 (実際)
2014年1月1日
研究の完了 (実際)
2014年1月1日
試験登録日
最初に提出
2014年9月17日
QC基準を満たした最初の提出物
2014年9月19日
最初の投稿 (見積もり)
2014年9月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月22日
QC基準を満たした最後の更新が送信されました
2014年9月19日
最終確認日
2014年9月1日
詳しくは
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