Dysgeusia, Lung Neoplasms, Non-Small Cell Lung Cancer, Small Cell Lung Carcinoma, Taste Disorders
Conditions
Keywords
Non-Small Cell Lung Cancer, Dysgeusia, Antineoplastic Combined Chemotherapy Protocols, Paclitaxel, Cisplatin
Brief summary
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.
Detailed description
Lung cancer is the leading cause of death from malignancies in our country. It was recently reported to induce 11.5% of cancer deaths in Mexico, with a rate of 6.5 per 100 000 people. Non-Small Cell Lung Cancer (NSCLC) accounts for 80% of all lung cancer cases. Less than 20% has resectable disease and in the National Cancer Institute of Mexico exclusively less than 2%, representing chemotherapy the standard of care in these patients. One of the most widely used drug combinations is paclitaxel-cisplatin. It has been reported a prevalence of malnutrition in 60 to 79% in this type of cancer, being the major contributor to morbidity and mortality. The etiology resides both in the systemic effects of the tumor and toxic effects of treatment as low levels hematologic, nausea, vomiting, mucositis, anorexia, dysgeusia, among others. Weight loss has a strong impact on the response to chemotherapy, radiotherapy and surgery, as well as increased toxic effects impacting the discontinuation of treatment and is considered an independent predictor of survival for most patients with NSCLC. Is estimated that over 20% of cancer patients the cause of death are inanition effects. Among the most frequent symptoms in advanced unresectable cancer or its treatment that may affect food intake and hence nutritional status, are the early satiety and dysgeusia (61% and 46% respectively). As are difficult to change early satiety, dysgeusia is a field for selecting strategies in its management. The dysgeusia is defined as a change in taste that can manifest as a distortion of taste, lack of taste (ageusia), decreased sensitivity of perception (hypogeusia) or increased sensitivity to some or all flavors (hypergeusia). The development of dysgeusia have clinical significance in the etiology of cancer anorexia because it can affect eating habits and contribute to weight loss or malnutrition and consequently affect the quality of life. The chemotherapy may contribute to dysgeusia. It has reported a prevalence of 56.3% of Dysgeusia in cancer patients under this type of treatment. As well, zinc deficiency has been associated with the hypogeusia, this metal to be involved at various levels in the physiology of the role of taste at various levels of cell several organization. Several studies have linked consumption dysgeusia with energy and macronutrients, weight loss, lack of appetite and early satiety. The type of tumor, stage, chemotherapy regimen and serum zinc levels are associated with dysgeusia, but the exact mechanism underlining these disturbances are not known at totality. No known if chemotherapy or before this is presented dysgeusia. In addition there are few studies in this area and with methodological weaknesses, among which include heterogeneous population (patients with a diagnosis of malignancy of breast, lung, prostate, multiple myeloma and lymphoma), different patterns of treatment(different chemotherapy drugs, radiotherapy schedules and combination of both forms of measurement of dysgeusia, besides the absence of dysgeusia baseline evaluation before chemotherapy to establish a causal association between chemotherapy and taste alteration. Also, is unknown if dysgeusia impact on body composition determined by bioelectrical impedance, phase angle in and consumption of micronutrients (iron, sodium, zinc, B6, B12). That's why is necessary to continue studying this phenomenon to develop a better understanding of the nature, frequency, severity and duration of dysgeusia in patients with advanced lung cancer, the role that zinc exerts in its development and its impact on consumption food, anthropometric parameters and quality of life in such patients before and after chemotherapy in the same regimen of chemotherapy.
Interventions
None listed
Sponsors
Instituto Nacional de Cancerologia de Mexico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dysgeusia (BITTER Dilutions Dichotomized) | 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 |
| Dysgeusia (UMAMI Perception) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | pre - post chemotherapy (6 weeks) | We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BODY COMPOSITION | Change from Baseline in perception and recognition thresholds at 6 weeks | fat mass and lean body mass pre-post chemotherapy |
| Body Mass Index | Change from Baseline in threshold of perception and recognition at 6 weeks | Body mass index, using the formula kg/m\^2 |
| Subjective Global Assessment | 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 | 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 | 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 | 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 | 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) | 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 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. |
Countries
Mexico
Participant flow
Recruitment details
We recruit patients since September 2010 to July 2012
Pre-assignment details
We invited to participate 40 patients who completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.
Participants by arm
| Arm | Count |
|---|---|
| Pre-chemotherapy Patientes =40 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 | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Pre-chemotherapy Patientes =40 |
|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 15 |
| Region of Enrollment Mexico | 40 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Dysgeusia (BITTER Dilutions Dichotomized)
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes
Time frame: pre - post chemotherapy (6 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (BITTER Dilutions Dichotomized) | BITTER 91 - 103 μmol/ml | 26 participants |
| Pre-chemotherapy Patientes | Dysgeusia (BITTER Dilutions Dichotomized) | BITTER > 109 μmol/ml | 14 participants |
| Post-chemotherapy Patients | Dysgeusia (BITTER Dilutions Dichotomized) | BITTER 91 - 103 μmol/ml | 35 participants |
| Post-chemotherapy Patients | Dysgeusia (BITTER Dilutions Dichotomized) | BITTER > 109 μmol/ml | 4 participants |
Comparison: We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)p-value: 0.022McNemar
Primary
Dysgeusia (BITTER Perception)
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.
Time frame: Change from Baseline in threshold of perception at 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (BITTER Perception) | 97 μmol/ml |
| Post-chemotherapy Patients | Dysgeusia (BITTER Perception) | 91 μmol/ml |
Comparison: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.p-value: 0.035Wilcoxon (Mann-Whitney)
Primary
Dysgeusia (BITTER Recognition)
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.
Time frame: Change from Baseline in threshold of perception at 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (BITTER Recognition) | 115 μmol/ml |
| Post-chemotherapy Patients | Dysgeusia (BITTER Recognition) | 109 μmol/ml |
Comparison: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.p-value: 0.402Wilcoxon (Mann-Whitney)
Primary
Dysgeusia (SWEET Dilutions Dichotomized)
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.
Time frame: pre - post chemotherapy (6 weeks)
Population: we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (SWEET Dilutions Dichotomized) | SWEET 3.5 - 9.5 μmol/ml | 26 participants |
| Pre-chemotherapy Patientes | Dysgeusia (SWEET Dilutions Dichotomized) | SWEET > 9.5 μmol/ml | 14 participants |
| Post-chemotherapy Patients | Dysgeusia (SWEET Dilutions Dichotomized) | SWEET 3.5 - 9.5 μmol/ml | 33 participants |
| Post-chemotherapy Patients | Dysgeusia (SWEET Dilutions Dichotomized) | SWEET > 9.5 μmol/ml | 6 participants |
Comparison: for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.p-value: 0.092McNemar
Primary
Dysgeusia (SWEET Perception)
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.
Time frame: Change from Baseline in threshold of perception at 6 weeks
Population: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (SWEET Perception) | 3.5 μmol/ml |
| Post-chemotherapy Patients | Dysgeusia (SWEET Perception) | 3.5 μmol/ml |
Comparison: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.p-value: 0.312Wilcoxon (Mann-Whitney)
Primary
Dysgeusia (SWEET Recognition)
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.
Time frame: Change from Baseline in threshold of perception at 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (SWEET Recognition) | 15.5 μmol/ml |
| Post-chemotherapy Patients | Dysgeusia (SWEET Recognition) | 12.5 μmol/ml |
Comparison: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.p-value: 0.608Wilcoxon (Mann-Whitney)
Primary
Dysgeusia (UMAMI Dilutions Dichotomized)
We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)
Time frame: pre - post chemotherapy (6 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (UMAMI Dilutions Dichotomized) | UMAMI 0.3 - 1.5 μmol/ml | 31 participants |
| Pre-chemotherapy Patientes | Dysgeusia (UMAMI Dilutions Dichotomized) | UMAMI > 1.5 μmol/ml | 9 participants |
| Post-chemotherapy Patients | Dysgeusia (UMAMI Dilutions Dichotomized) | UMAMI 0.3 - 1.5 μmol/ml | 36 participants |
| Post-chemotherapy Patients | Dysgeusia (UMAMI Dilutions Dichotomized) | UMAMI > 1.5 μmol/ml | 3 participants |
Comparison: for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.p-value: 0.109McNemar
Primary
Dysgeusia (UMAMI Perception)
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.
Time frame: Change from Baseline in threshold of perception at 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (UMAMI Perception) | .3 μmol/ml |
| Post-chemotherapy Patients | Dysgeusia (UMAMI Perception) | .3 μmol/ml |
Comparison: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.p-value: 0.013Wilcoxon (Mann-Whitney)
Primary
Dysgeusia (UMAMI Recognition)
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.
Time frame: Change from Baseline in threshold of perception at 6 weeks
Population: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Dysgeusia (UMAMI Recognition) | 2.4 μmol/ml |
| Post-chemotherapy Patients | Dysgeusia (UMAMI Recognition) | 1.5 μmol/ml |
Comparison: For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.p-value: 0.28Wilcoxon (Mann-Whitney)
Secondary
BODY COMPOSITION
fat mass and lean body mass pre-post chemotherapy
Time frame: Change from Baseline in perception and recognition thresholds at 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pre-chemotherapy Patientes | BODY COMPOSITION | FAT MASS (kg) | 20.09 kg | Standard Deviation 7.7 |
| Pre-chemotherapy Patientes | BODY COMPOSITION | LEAN BODY MASS (kg) | 41.79 kg | Standard Deviation 13 |
| Post-chemotherapy Patients | BODY COMPOSITION | FAT MASS (kg) | 19.67 kg | Standard Deviation 6.5 |
| Post-chemotherapy Patients | BODY COMPOSITION | LEAN BODY MASS (kg) | 41.26 kg | Standard Deviation 11.9 |
Comparison: we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapyp-value: 0.671t-test, 2 sided
Comparison: we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapyp-value: 0.694t-test, 2 sided
Secondary
Body Mass Index
Body mass index, using the formula kg/m\^2
Time frame: Change from Baseline in threshold of perception and recognition at 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-chemotherapy Patientes | Body Mass Index | 24.5 kg/m^2 | Standard Deviation 4 |
| Post-chemotherapy Patients | Body Mass Index | 24.1 kg/m^2 | Standard Deviation 4 |
p-value: 0.118t-test, 2 sided
Secondary
Change From Baseline in Albumin After 2 Cycles of Chemotherapy
comparison of patients who increased or decreased their sensibility to the PT of umami taste
Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-chemotherapy Patientes | Change From Baseline in Albumin After 2 Cycles of Chemotherapy | -0.4 g/dL | Standard Deviation 0.11 |
| Post-chemotherapy Patients | Change From Baseline in Albumin After 2 Cycles of Chemotherapy | 0.28 g/dL | Standard Deviation 0.1 |
p-value: 0.05t-test, 2 sided
Secondary
Global Status of Quality of Life (C-30,LC13 EORTC)
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.
Time frame: time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Global Status of Quality of Life (C-30,LC13 EORTC) | 75 units on a scale |
| Post-chemotherapy Patients | Global Status of Quality of Life (C-30,LC13 EORTC) | 66.67 units on a scale |
Comparison: change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.036Wilcoxon (Mann-Whitney)
Secondary
IRON Consumption
IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy
Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-chemotherapy Patientes | IRON Consumption | 10.8 mg | Standard Deviation 7.5 |
| Post-chemotherapy Patients | IRON Consumption | 16.11 mg | Standard Deviation 6.3 |
Secondary
Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)
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.
Time frame: participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-chemotherapy Patientes | Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) | 33.33 Units on a scale |
| Post-chemotherapy Patients | Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) | 16.66 Units on a scale |
Comparison: change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.24Wilcoxon (Mann-Whitney)
Secondary
PROTEIN AND FAT Consumption
energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy
Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pre-chemotherapy Patientes | PROTEIN AND FAT Consumption | fat | 60.1 gr | Standard Deviation 26.2 |
| Pre-chemotherapy Patientes | PROTEIN AND FAT Consumption | proteins | 59.12 gr | Standard Deviation 32.7 |
| Pre-chemotherapy Patientes | PROTEIN AND FAT Consumption | animal proteins | 28.2 gr | Standard Deviation 14 |
| Post-chemotherapy Patients | PROTEIN AND FAT Consumption | proteins | 91.07 gr | Standard Deviation 33.1 |
| Post-chemotherapy Patients | PROTEIN AND FAT Consumption | animal proteins | 49.29 gr | Standard Deviation 18.5 |
| Post-chemotherapy Patients | PROTEIN AND FAT Consumption | fat | 91.77 gr | Standard Deviation 31.6 |
Comparison: protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapyp-value: 0.015t-test, 2 sided
Comparison: animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapyp-value: 0.01t-test, 2 sided
Comparison: FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapyp-value: 0.004t-test, 2 sided
Secondary
Quality o f Life
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.
Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pre-chemotherapy Patientes | Quality o f Life | Fatigue | 38.8 Scores on a scale |
| Pre-chemotherapy Patientes | Quality o f Life | Emotional functioning | 66.67 Scores on a scale |
| Pre-chemotherapy Patientes | Quality o f Life | Appetite loss | 33.33 Scores on a scale |
| Pre-chemotherapy Patientes | Quality o f Life | Role functioning | 66.67 Scores on a scale |
| Pre-chemotherapy Patientes | Quality o f Life | Constipation | 33.33 Scores on a scale |
| Pre-chemotherapy Patientes | Quality o f Life | Global status | 58.33 Scores on a scale |
| Post-chemotherapy Patients | Quality o f Life | Constipation | 0 Scores on a scale |
| Post-chemotherapy Patients | Quality o f Life | Global status | 66.67 Scores on a scale |
| Post-chemotherapy Patients | Quality o f Life | Emotional functioning | 91.67 Scores on a scale |
| Post-chemotherapy Patients | Quality o f Life | Fatigue | 22.22 Scores on a scale |
| Post-chemotherapy Patients | Quality o f Life | Appetite loss | 0 Scores on a scale |
| Post-chemotherapy Patients | Quality o f Life | Role functioning | 83.33 Scores on a scale |
Comparison: change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.889Wilcoxon (Mann-Whitney)
Comparison: change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.293Wilcoxon (Mann-Whitney)
Comparison: change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.009Wilcoxon (Mann-Whitney)
Comparison: change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.213Wilcoxon (Mann-Whitney)
Comparison: change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.595Wilcoxon (Mann-Whitney)
Comparison: change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnairep-value: 0.068Wilcoxon (Mann-Whitney)
Secondary
Subjective Global Assessment
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).
Time frame: descriptive values before chemotherapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-chemotherapy Patientes | Subjective Global Assessment | SGA A | 26 participants |
| Pre-chemotherapy Patientes | Subjective Global Assessment | SGA B & C | 14 participants |
| Post-chemotherapy Patients | Subjective Global Assessment | SGA A | 23 participants |
| Post-chemotherapy Patients | Subjective Global Assessment | SGA B & C | 17 participants |
Comparison: 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).p-value: 0.607McNemar