Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01540045 |
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Recruitment Status
:
Completed
First Posted
: February 28, 2012
Results First Posted
: March 18, 2015
Last Update Posted
: March 18, 2015
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| Condition or disease |
|---|
| Non-Small Cell Lung Cancer Dysgeusia Taste Disorders Lung Neoplasms Small Cell Lung Carcinoma |
Show Detailed Description
| Study Type : | Observational |
| Actual Enrollment : | 40 participants |
| 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 |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | May 2012 |
| Group/Cohort |
|---|
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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
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- 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
- 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.
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| 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 |
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.
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
| Mexico | |
| National Cancer Institute of Mexico | |
| Mexico city, Distrito Federal, Mexico, 14080 | |
| Principal Investigator: | Oscar G Arrieta, MD M Sc | Mexico. Nacional Cancer Institute |
Publications of Results:
Other Publications:
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 Posted: | February 28, 2012 Key Record Dates |
| 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:
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Non-Small Cell Lung Cancer Dysgeusia Antineoplastic Combined Chemotherapy Protocols Paclitaxel Cisplatin |
Additional relevant MeSH terms:
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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 |