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Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540045
First Posted: February 28, 2012
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
  Purpose
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.

Condition
Non-Small Cell Lung Cancer Dysgeusia Taste Disorders Lung Neoplasms Small Cell Lung Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:

Primary Outcome Measures:
  • Dysgeusia (UMAMI Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

    Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations.

    The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.


  • Dysgeusia (UMAMI Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

    Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations.

    The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.


  • Dysgeusia (SWEET Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

    Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations.

    The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.


  • Dysgeusia (SWEET Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

    Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations.

    The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.


  • Dysgeusia (BITTER Perception) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

    Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations.

    The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.


  • Dysgeusia (BITTER Recognition) [ Time Frame: Change from Baseline in threshold of perception at 6 weeks ]

    Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations.

    The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.


  • Dysgeusia (UMAMI Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ]
    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)

  • Dysgeusia (SWEET Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ]
    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.

  • Dysgeusia (BITTER Dilutions Dichotomized) [ Time Frame: pre - post chemotherapy (6 weeks) ]
    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes


Secondary Outcome Measures:
  • BODY COMPOSITION [ Time Frame: Change from Baseline in perception and recognition thresholds at 6 weeks ]
    fat mass and lean body mass pre-post chemotherapy

  • Body Mass Index [ Time Frame: Change from Baseline in threshold of perception and recognition at 6 weeks ]
    Body mass index, using the formula kg/m^2

  • Subjective Global Assessment [ Time Frame: descriptive values before chemotherapy ]
    validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).

  • PROTEIN AND FAT Consumption [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
    energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy

  • IRON Consumption [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
    IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy

  • Quality o f Life [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
    The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.

  • Change From Baseline in Albumin After 2 Cycles of Chemotherapy [ Time Frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks ]
    comparison of patients who increased or decreased their sensibility to the PT of umami taste

  • Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) [ Time Frame: participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks ]
    comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.

  • Global Status of Quality of Life (C-30,LC13 EORTC) [ Time Frame: time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks ]

    differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste.

    score of scale 0-100, a higher score represents better overall state.



Enrollment: 40
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
BASELINE
Outpatients 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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients 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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540045


Locations
Mexico
National Cancer Institute of Mexico
Mexico city, Distrito Federal, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Oscar G Arrieta, MD M Sc Mexico. Nacional Cancer Institute
  More Information

Publications:
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.
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.
Sarhill N, Mahmoud FA, Christie R, Tahir A. Assessment of nutritional status and fluid deficits in advanced cancer. Am J Hosp Palliat Care. 2003 Nov-Dec;20(6):465-73. Review.
Wie GA, Cho YA, Kim SY, Kim SM, Bae JM, Joung H. Prevalence and risk factors of malnutrition among cancer patients according to tumor location and stage in the National Cancer Center in Korea. Nutrition. 2010 Mar;26(3):263-8. doi: 10.1016/j.nut.2009.04.013. Epub 2009 Aug 8.
Arrieta O, Michel Ortega RM, Villanueva-Rodríguez G, Serna-Thomé MG, Flores-Estrada D, Diaz-Romero C, Rodríguez CM, Martínez L, Sánchez-Lara K. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study. BMC Cancer. 2010 Feb 21;10:50. doi: 10.1186/1471-2407-10-50.
Halyard MY. Taste and smell alterations in cancer patients--real problems with few solutions. J Support Oncol. 2009 Mar-Apr;7(2):68-9.
Hong JH, Omur-Ozbek P, Stanek BT, Dietrich AM, Duncan SE, Lee YW, Lesser G. Taste and odor abnormalities in cancer patients. J Support Oncol. 2009 Mar-Apr;7(2):58-65. Review.
Rolls ET. The representation of umami taste in the taste cortex. J Nutr. 2000 Apr;130(4S Suppl):960S-5S. Review.
Comeau TB, Epstein JB, Migas C. Taste and smell dysfunction in patients receiving chemotherapy: a review of current knowledge. Support Care Cancer. 2001 Nov;9(8):575-80. Review.
Arrieta Ó, Hernández-Pedro N, Fernández-González-Aragón MC, Saavedra-Pérez D, Campos-Parra AD, Ríos-Trejo MÁ, Cerón-Lizárraga T, Martínez-Barrera L, Pineda B, Ordóñez G, Ortiz-Plata A, Granados-Soto V, Sotelo J. Retinoic acid reduces chemotherapy-induced neuropathy in an animal model and patients with lung cancer. Neurology. 2011 Sep 6;77(10):987-95. doi: 10.1212/WNL.0b013e31822e045c. Epub 2011 Aug 24.
Bernhardson BM, Tishelman C, Rutqvist LE. Self-reported taste and smell changes during cancer chemotherapy. Support Care Cancer. 2008 Mar;16(3):275-83. Epub 2007 Aug 21.
Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37.
Hernández-Avila M, Romieu I, Parra S, Hernández-Avila J, Madrigal H, Willett W. Validity and reproducibility of a food frequency questionnaire to assess dietary intake of women living in Mexico City. Salud Publica Mex. 1998 Mar-Apr;40(2):133-40.
Thoresen L, Fjeldstad I, Krogstad K, Kaasa S, Falkmer UG. Nutritional status of patients with advanced cancer: the value of using the subjective global assessment of nutritional status as a screening tool. Palliat Med. 2002 Jan;16(1):33-42.
Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85.
Muscaritoli M, Anker SD, Argilés J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8.
Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Head Of the Thoracic Oncology Clinic. SNI II, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01540045     History of Changes
Other Study ID Numbers: ECPCDLC2012
First Submitted: January 13, 2012
First Posted: February 28, 2012
Results First Submitted: July 23, 2013
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
Non-Small Cell Lung Cancer
Dysgeusia
Antineoplastic Combined Chemotherapy Protocols
Paclitaxel
Cisplatin

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Dysgeusia
Taste Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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