Non-Small Cell Lung Cancer | Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer research study
What is the primary objective of this study?
One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight loss and malnutrition, which leads to a prognostic impact in a lower patient response to chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects, impacting treatment discontinuation and therefore, morbidity and survival of patients. The objective of this study is to describe the threshold of perception and recognition of basic tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy and after the second cycle, and analyze the effect in the developement of dysgeusia, as well as the association between these and the nutritional status and quality of life.
Who is eligible to participate?
Inclusion Criteria: - Patients over 18 years old with INCan histopathological diagnosis of Lung Cancer Stage III or IV - ECOG score ≤ 2 - Candidates for first-line chemotherapy based 1 st Paclitaxel / cisplatin 200 mg/m2 and 75 every 3 weeks - Signed informed consent (and ethical scientific committee No. (010/023 (IMO) (CB/618 Exclusion Criteria: - Patients who withdraw their consent and not want to continue with the evaluation of the study - Common cold or hay fever, recent dental procedure, evidence of gingival inflammation or infection or oral mucosa - People diagnosed with epilepsy or some other neurological disorders associated - Concomitant radiotherapy in head and neck.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Non-Small Cell Lung Cancer
Small Cell Lung Carcinoma
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
BASELINEOutpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
Start Date: December 2010
Completed Date: May 2012
Primary Outcome: Dysgeusia (UMAMI Perception)
Secondary Outcome: BODY COMPOSITION
Study sponsors, principal investigator, and references
Principal Investigator: Oscar G Arrieta, MD M Sc
Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
Ruíz-Godoy L, Rizo Rios P, Sánchez Cervantes F, Osornio-Vargas A, García-Cuellar C, Meneses García A. Mortality due to lung cancer in Mexico. Lung Cancer. 2007 Nov;58(2):184-90. Epub 2007 Jul 30.
Brennan MT, Elting LS, Spijkervet FK. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO: methodology and quality of the literature. Support Care Cancer. 2010 Aug;18(8):979-84. doi: 10.1007/s00520-010-0856-3. Epub 2010 Mar 20. Review.
Gallagher P, Tweedle DE. Taste threshold and acceptability of commercial diets in cancer patients. JPEN J Parenter Enteral Nutr. 1983 Jul-Aug;7(4):361-3.
Mattes RD, Cowart BJ, Schiavo MA, Arnold C, Garrison B, Kare MR, Lowry LD. Dietary evaluation of patients with smell and/or taste disorders. Am J Clin Nutr. 1990 Feb;51(2):233-40.
Hutton JL, Baracos VE, Wismer WV. Chemosensory dysfunction is a primary factor in the evolution of declining nutritional status and quality of life in patients with advanced cancer. J Pain Symptom Manage. 2007 Feb;33(2):156-65.
Rehwaldt M, Wickham R, Purl S, Tariman J, Blendowski C, Shott S, Lappe M. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum. 2009 Mar;36(2):E47-56. doi: 10.1188/09.ONF. E47-E56.
Steinbach S, Hummel T, Böhner C, Berktold S, Hundt W, Kriner M, Heinrich P, Sommer H, Hanusch C, Prechtl A, Schmidt B, Bauerfeind I, Seck K, Jacobs VR, Schmalfeldt B, Harbeck N. Qualitative and quantitative assessment of taste and smell changes in patients undergoing chemotherapy for breast cancer or gynecologic malignancies. J Clin Oncol. 2009 Apr 10;27(11):1899-905. doi: 10.1200/JCO.2008.19.2690. Epub 2009 Mar 16.
Zabernigg A, Gamper EM, Giesinger JM, Rumpold G, Kemmler G, Gattringer K, Sperner-Unterweger B, Holzner B. Taste alterations in cancer patients receiving chemotherapy: a neglected side effect? Oncologist. 2010;15(8):913-20. doi: 10.1634/theoncologist.2009-0333. Epub 2010 Jul 28.
Sánchez-Lara K, Sosa-Sánchez R, Green-Renner D, Rodríguez C, Laviano A, Motola-Kuba D, Arrieta O. Influence of taste disorders on dietary behaviors in cancer patients under chemotherapy. Nutr J. 2010 Mar 24;9:15. doi: 10.1186/1475-2891-9-15.
Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.