頭頸部がんにおける栄養補給
A Randomized Open Label Trial of Multimodal Oral Nutritional Supplementation Versus Standard Care, to Prevent / Attenuate Malnutrition in Patients With Cancers of the Head and Neck Receiving (Chemo)-Radiotherapy Treatment.
The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.
調査の概要
詳細な説明
This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Alberta
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Edmonton、Alberta、カナダ、T6G 1Z2
- Cross Cancer Institute
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
- Male or female
- ≥18 years of age
- Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy
- Capable of volitional oral nutritional intake at baseline.
- A diagnostic CT image taken with a maximum of 30 days before initiation of radical intent radiotherapy. If the CT scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced CT abdomen will be conducted.
- An Eastern Cooperative Oncology Group Performance Status of ≤ 2
Exclusion Criteria:
- Fed by nasogastric tube, gastrostomy or total parenteral nutrition
- Cancer of the nasopharynx, thyroid or salivary gland
- Life expectancy <6 months.
- A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
- Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
- Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
- Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
- In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Multimodal Nutrition Therapy
To assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient). Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition. BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy. |
Nestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and/or radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA). |
|
介入なし：Standard of Care
In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian. |
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 |
|---|---|---|
|
Change in mean cumulative energy intake
時間枠：Up to 14 weeks
|
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14). |
Up to 14 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in mean cumulative protein take
時間枠：Up to 14 Weeks
|
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14) |
Up to 14 Weeks
|
|
Change in body weight (kg)
時間枠：Baseline-Week 14
|
Change in weight (kg) from the previous week. |
Baseline-Week 14
|
|
Change in Nutritional blood biomarkers
時間枠：Baseline measures will be compared to levels at weeks 7 and 14
|
A sample of blood will be collected for albumin, absolute neutrophil count, lymphocyte count, C-reactive protein, standard complete blood count-differential White Blood cell count and to measure serum CRP and albumin |
Baseline measures will be compared to levels at weeks 7 and 14
|
|
Head and Neck Symptom Checklist
時間枠：Up to 14 weeks
|
A survey tool for HNC patient self-assessment of the presence and degree of interference with eating, over the past 3 days, of 17 symptoms known to impact dietary intake. Scores range from 34 to 170 pts, where higher scores reflect a greater presence and interference with eating. Completed at weeks 0, 4, 7, 11, 14 |
Up to 14 weeks
|
|
Taste and smell survey
時間枠：Up to 14 weeks
|
A survey tool for patient self-assessment of the presence, characterization and severity of taste and smell alterations. This tool yields a 'chemosensory complaint score' of up to 16 (greatest severity of taste and smell alterations). Completed at weeks 0, 4, 7, 11, 14. |
Up to 14 weeks
|
|
Medication use for pain
時間枠：Up to 14 weeks
|
Use of pain medication will be captured weekly by a one- day pain medication log. |
Up to 14 weeks
|
|
Percent oral intake from oral nutritional supplements
時間枠：Up to 14 weeks
|
The volume (mL) of study products consumed will be determined from the weekly one-day diet record. |
Up to 14 weeks
|
|
Product Sensory Assessment questionnaire
時間枠：Up to 14 weeks
|
A product evaluation form for the Medical Nutrition products will be used to evaluate product overall sensory assessment, including acceptance and perception of characteristic product attributes that influence overall sensory acceptance. Medical Nutrition sensory acceptance will be evaluated by "overall liking" on the 9-point hedonic scale (1= dislike extremely; 9 = like extremely). Completed at weeks 0, 2, 4, 6, 8, 10, 12, 14. |
Up to 14 weeks
|
|
Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)
時間枠：Up to 14 weeks
|
The FAACT is a validated Quality of Life Scale to capture patient experience of cancer related cachexia - anorexia. Completed at weeks 0, 4, 7,11, 14 |
Up to 14 weeks
|
|
Cumulative energy intake (kcal/kg BW)
時間枠：Up to 14 weeks
|
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14) |
Up to 14 weeks
|
|
Cumulative protein take (g pro/kg BW)
時間枠：Up to 14 weeks
|
Protein intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14) |
Up to 14 weeks
|
|
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
時間枠：Within 30 days prior to start of treatment, Week 14
|
Imaging for body composition (muscle, fat) |
Within 30 days prior to start of treatment, Week 14
|
|
Tertiary hospital admission
時間枠：Up to 14 weeks
|
Review of patient medical records for instances of hospitalization with date(s) of admission falling between baseline and week 14 of study. |
Up to 14 weeks
|
協力者と研究者
捜査官
- 主任研究者：Vickie Baracos、Cross Cancer Institute, Alberta Health Services
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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