N/A
N=40
Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer · Dysgeusia · Taste Disorders · Lung Neoplasms · Small Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01540045 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Mar 2015
Primary outcome: Primary: Dysgeusia (UMAMI Perception) — .3; .3 μmol/ml — p=0.013
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dysgeusia (UMAMI Perception) |
.3; .3 | 0.013 sig |
| PRIMARY Dysgeusia (UMAMI Recognition) |
2.4; 1.5 | 0.28 |
| PRIMARY Dysgeusia (SWEET Perception) |
3.5; 3.5 | 0.312 |
| PRIMARY Dysgeusia (SWEET Recognition) |
15.5; 12.5 | 0.608 |
| PRIMARY Dysgeusia (BITTER Perception) |
97; 91 | 0.035 sig |
| PRIMARY Dysgeusia (BITTER Recognition) |
115; 109 | 0.402 |
| PRIMARY Dysgeusia (UMAMI Dilutions Dichotomized) |
31; 36; 9; 3 | 0.109 |
| PRIMARY Dysgeusia (SWEET Dilutions Dichotomized) |
26; 33; 14; 6 | 0.092 |
| PRIMARY Dysgeusia (BITTER Dilutions Dichotomized) |
26; 35; 14; 4 | 0.022 sig |
| SECONDARY BODY COMPOSITION |
20.09; 19.67; 41.79; 41.26 | 0.671 |
| SECONDARY Body Mass Index |
24.5; 24.1 | 0.118 |
| SECONDARY Subjective Global Assessment |
26; 23; 14; 17 | 0.607 |
| SECONDARY PROTEIN AND FAT Consumption |
59.12; 91.07; 28.2; 49.29; 60.1; 91.77 | 0.015 sig |
| SECONDARY IRON Consumption |
10.8; 16.11 | — |
| SECONDARY Quality o f Life |
58.33; 66.67; 66.67; 83.33; 66.67; 91.67 | 0.889 |
| SECONDARY Change From Baseline in Albumin After 2 Cycles of Chemotherapy |
-0.4; 0.28 | 0.05 |
| SECONDARY Peripheral Neuropathy (QLQ-C30 Version 3, EORTC) |
33.33; 16.66 | 0.240 |
| SECONDARY Global Status of Quality of Life (C-30,LC13 EORTC) |
75; 66.67 | 0.036 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01540045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.