Trial Outcomes & Findings for Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer (NCT NCT01540045)

NCT ID: NCT01540045

Last Updated: 2024-02-28

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 40 participants
• Primary outcome timeframe: Change from Baseline in threshold of perception at 6 weeks
• Results posted on: 2024-02-28

Participant Flow

We recruit patients since September 2010 to July 2012

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.

Participant milestones

Measure	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
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pre-chemotherapy Patientes =40 n=40 Participants 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
Age, Continuous	55.5 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment Mexico	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (UMAMI Perception)	.3 μmol/ml Interval 0.3 to 3.3	.3 μmol/ml Interval 0.3 to 2.7

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (UMAMI Recognition)	2.4 μmol/ml Interval 0.3 to 3.3	1.5 μmol/ml Interval 0.3 to 3.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (SWEET Perception)	3.5 μmol/ml Interval 3.5 to 18.5	3.5 μmol/ml Interval 3.5 to 18.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (SWEET Recognition)	15.5 μmol/ml Interval 3.5 to 18.5	12.5 μmol/ml Interval 3.5 to 18.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (BITTER Perception)	97 μmol/ml Interval 91.0 to 121.0	91 μmol/ml Interval 91.0 to 121.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (BITTER Recognition)	115 μmol/ml Interval 91.0 to 121.0	109 μmol/ml Interval 91.0 to 121.0

PRIMARY outcome

Timeframe: pre - post chemotherapy (6 weeks)

We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (UMAMI Dilutions Dichotomized) UMAMI 0.3 - 1.5 μmol/ml	31 participants	36 participants
Dysgeusia (UMAMI Dilutions Dichotomized) UMAMI > 1.5 μmol/ml	9 participants	3 participants

PRIMARY outcome

Timeframe: pre - post chemotherapy (6 weeks)

Population: we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy

We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (SWEET Dilutions Dichotomized) SWEET > 9.5 μmol/ml	14 participants	6 participants
Dysgeusia (SWEET Dilutions Dichotomized) SWEET 3.5 - 9.5 μmol/ml	26 participants	33 participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=39 Participants measurement post-chemotherapy
Dysgeusia (BITTER Dilutions Dichotomized) BITTER 91 - 103 μmol/ml	26 participants	35 participants
Dysgeusia (BITTER Dilutions Dichotomized) BITTER > 109 μmol/ml	14 participants	4 participants

SECONDARY outcome

Timeframe: Change from Baseline in perception and recognition thresholds at 6 weeks

fat mass and lean body mass pre-post chemotherapy

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=40 Participants measurement post-chemotherapy
BODY COMPOSITION FAT MASS (kg)	20.09 kg Standard Deviation 7.7	19.67 kg Standard Deviation 6.5
BODY COMPOSITION LEAN BODY MASS (kg)	41.79 kg Standard Deviation 13	41.26 kg Standard Deviation 11.9

SECONDARY outcome

Timeframe: Change from Baseline in threshold of perception and recognition at 6 weeks

Body mass index, using the formula kg/m^2

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=40 Participants measurement post-chemotherapy
Body Mass Index	24.5 kg/m^2 Standard Deviation 4	24.1 kg/m^2 Standard Deviation 4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=40 Participants measurement post-chemotherapy
Subjective Global Assessment SGA A	26 participants	23 participants
Subjective Global Assessment SGA B & C	14 participants	17 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pre-chemotherapy Patientes n=29 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=11 Participants measurement post-chemotherapy
PROTEIN AND FAT Consumption proteins	59.12 gr Standard Deviation 32.7	91.07 gr Standard Deviation 33.1
PROTEIN AND FAT Consumption animal proteins	28.2 gr Standard Deviation 14	49.29 gr Standard Deviation 18.5
PROTEIN AND FAT Consumption fat	60.1 gr Standard Deviation 26.2	91.77 gr Standard Deviation 31.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pre-chemotherapy Patientes n=29 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=11 Participants measurement post-chemotherapy
IRON Consumption	10.8 mg Standard Deviation 7.5	16.11 mg Standard Deviation 6.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=40 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=40 Participants measurement post-chemotherapy
Quality o f Life Constipation	33.33 Scores on a scale Interval 0.0 to 100.0	0 Scores on a scale Interval 0.0 to 100.0
Quality o f Life Global status	58.33 Scores on a scale Interval 0.0 to 100.0	66.67 Scores on a scale Interval 0.0 to 100.0
Quality o f Life Role functioning	66.67 Scores on a scale Interval 0.0 to 100.0	83.33 Scores on a scale Interval 0.0 to 100.0
Quality o f Life Emotional functioning	66.67 Scores on a scale Interval 0.0 to 100.0	91.67 Scores on a scale Interval 0.0 to 100.0
Quality o f Life Fatigue	38.8 Scores on a scale Interval 0.0 to 100.0	22.22 Scores on a scale Interval 0.0 to 100.0
Quality o f Life Appetite loss	33.33 Scores on a scale Interval 0.0 to 100.0	0 Scores on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pre-chemotherapy Patientes n=34 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=6 Participants measurement post-chemotherapy
Change From Baseline in Albumin After 2 Cycles of Chemotherapy	-0.4 g/dL Standard Deviation 0.11	0.28 g/dL Standard Deviation 0.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=30 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=6 Participants measurement post-chemotherapy
Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)	33.33 Units on a scale Interval 0.0 to 100.0	16.66 Units on a scale Interval 0.0 to 66.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-chemotherapy Patientes n=20 Participants measurement pre-chemotherapy	Post-chemotherapy Patients n=9 Participants measurement post-chemotherapy
Global Status of Quality of Life (C-30,LC13 EORTC)	75 units on a scale Interval 1.66 to 99.58	66.67 units on a scale Interval 8.33 to 100.0

Adverse Events

LUNG CANCER PATIENTS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Oscar Arrieta

Instituto Nacional de Cancerología de México

Phone: 5628-0400

Email: ogarrieta@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place