Plasma Levels of Glucagon-like Peptide-2 and Dyspepsia in Patients With Extraintestinal Cancer During Chemotherapy
Evaluation of Dyspeptic Symptoms in Oncological Frail Patients With Extraintestinal Cancer in Chemotherapy. Assessment of Circulating Levels of Glucagon-like Peptide 2 (GLP-2) in Relation to Mucositis
調査の概要
詳細な説明
The complications of anticancer treatment threaten the effectiveness of therapy because they lead to dose reduction, increase healthcare costs, and impair patients' quality of life. Gastrointestinal (GI) symptoms are the most frequent side effects of antineoplastic chemotherapy behind bone-marrow depression, with nausea and vomiting representing the mainly referred ones.
Gastrointestinal (GI) mucositis, which represents injury of the rest of the alimentary tract beyond oral mucositis, is becoming recognized increasingly as a toxicity associated with many standard-dose chemotherapy regimens. Although clinicians consider them "minor complaints", many patients (40-100%) treated with chemotherapy and/or exposed to ionizing radiation suffer from such a disease. After chemotherapy, GI mucositis is most prominent in the small intestine, but it also occurs in the esophagus, stomach, and large intestine. The GI symptoms related to mucositis mimic those from other GI disease (such as dyspepsia, reflux disease or abdominal pain and diarrhea). Alimentary tract mucositis increases morbility and mortality and contribute to rising health care cost.
The comprehension of pathophysiology will shed light on the rationale for targeting specific pathways and so for the use of specific agents for prevention and treatment. Since the role of chemotherapy in the onset of GI motility disorders in addition to minor GI complaints has not been clarified yet. Understanding the pathophysiology of mucositis, its measures and scores, are essential for progress in research and care direct at this common side-effect of anticancer therapy. Currently, there is not strong evidence to support a recommendation for and against the use of certain agents (mucosal surface protectants, antiinflammatory or antimicrobial agents, growth factors, etc).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Bari
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Castellana Grotte、Bari、イタリア、70013
- National Institute for Digestive Diseases IRCCS "S. de Bellis"
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients with newly diagnosed cancer (lung and breast cancer),
- Patients currently free of active disease
Exclusion Criteria:
- History of cerebral edema, primary and secondary brain neoplasm with signs and symptoms of raised intracranial pressure and/or brain metastases,
- Signs of marked hepatic or renal dysfunction, cardiac failure
- Signs of dyspepsia, peptic ulcer, gastric surgery or prior diagnosis of other cancer
- Administration of drugs interfering with GI motility (i.e. antisecretory, prokinetic, or antibiotic drugs) as well as the exposition to radiotherapy, four weeks prior to the examination
- Referred episode of nausea of any severity within 24 h prior to antiemetic therapy, if they had experienced vomiting in the previous 24 h,
- Pregnancy or lactating
- Concomitant administration of agents known to have significant antiemetic activity, including benzodiazepines and other corticosteroids
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
コホートと介入
グループ/コホート |
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GLP-2 and symptom evaluation
Before starting and at the end of the chemotherapy, along with a blood withdrawal for GLP-2 evaluation, a GSRS (gastrointestinal symptom rate scale) questionnaire will be filled by each patient to account for GI symptoms.
In addition, minor complaints such as warm sensation after chemotherapy, susceptibility to nausea under specific condition, sweating and weakness will scored by visual analog score (VAS).
Lastly, the NCI-CTC score for mucositis will be performed.
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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 |
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GLP-2 plasma levels in cancer patients
時間枠:21 days
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Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.
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21 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Cancer associated dyspepsia syndrome, mucositis and GLP-2 plasma levels
時間枠:21 days
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Evaluation of the symptom profile related to CADS (cancer associated dyspepsia syndrome) before and after the first cycle of chemotherapy. Assessment of possible relations between mucositis score, gastrointestinal symptom score and GLP-2 plasma levels. |
21 days
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協力者と研究者
捜査官
- 主任研究者:Caterina Clemente, ScD、National Institute of Digestive Diseases IRCCS "S. de Bellis"
出版物と役立つリンク
一般刊行物
- Riezzo G, Clemente C, Leo S, Russo F. The role of electrogastrography and gastrointestinal hormones in chemotherapy-related dyspeptic symptoms. J Gastroenterol. 2005 Dec;40(12):1107-15. doi: 10.1007/s00535-005-1708-7.
- Riezzo G, Chiloiro M, Russo F, Clemente C, Di Matteo G, Guerra V, Di Leo A. Gastric electrical activity and gastrointestinal hormones in dyspeptic patients. Digestion. 2001;63(1):20-9. doi: 10.1159/000051868.
- Drucker DJ. Biological actions and therapeutic potential of the glucagon-like peptides. Gastroenterology. 2002 Feb;122(2):531-44. doi: 10.1053/gast.2002.31068.
- Peterson DE, Cariello A. Mucosal damage: a major risk factor for severe complications after cytotoxic therapy. Semin Oncol. 2004 Jun;31(3 Suppl 8):35-44. doi: 10.1053/j.seminoncol.2004.04.006.
- Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
- Russo F, Linsalata M, Clemente C, D'Attoma B, Orlando A, Campanella G, Giotta F, Riezzo G. The effects of fluorouracil, epirubicin, and cyclophosphamide (FEC60) on the intestinal barrier function and gut peptides in breast cancer patients: an observational study. BMC Cancer. 2013 Feb 4;13:56. doi: 10.1186/1471-2407-13-56.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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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乳がんの臨床試験
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