Clinical trial NCT01540045: Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer
Official title: Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Dysgeusia
Taste Disorders
Lung Neoplasms
Small Cell Lung Carcinoma
Keywords: Non-Small Cell Lung Cancer
Dysgeusia
Antineoplastic Combined Chemotherapy Protocols
Paclitaxel
Cisplatin
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Dysgeusia (UMAMI Perception)
timeFrame: Change from Baseline in threshold of perception at 6 weeks
measure: Dysgeusia (UMAMI Recognition)
timeFrame: Change from Baseline in threshold of perception at 6 weeks
measure: Dysgeusia (SWEET Perception)
timeFrame: Change from Baseline in threshold of perception at 6 weeks
measure: Dysgeusia (SWEET Recognition)
timeFrame: Change from Baseline in threshold of perception at 6 weeks
measure: Dysgeusia (BITTER Perception)
timeFrame: Change from Baseline in threshold of perception at 6 weeks
measure: Dysgeusia (BITTER Recognition)
timeFrame: Change from Baseline in threshold of perception at 6 weeks
measure: Dysgeusia (UMAMI Dilutions Dichotomized)
timeFrame: pre - post chemotherapy (6 weeks)
measure: Dysgeusia (SWEET Dilutions Dichotomized)
timeFrame: pre - post chemotherapy (6 weeks)
measure: Dysgeusia (BITTER Dilutions Dichotomized)
timeFrame: pre - post chemotherapy (6 weeks)
Secondary outcomes:
measure: BODY COMPOSITION
timeFrame: Change from Baseline in perception and recognition thresholds at 6 weeks
measure: Body Mass Index
timeFrame: Change from Baseline in threshold of perception and recognition at 6 weeks
measure: Subjective Global Assessment
timeFrame: descriptive values before chemotherapy
measure: PROTEIN AND FAT Consumption
timeFrame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
measure: IRON Consumption
timeFrame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
measure: Quality o f Life
timeFrame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
measure: Change From Baseline in Albumin After 2 Cycles of Chemotherapy
timeFrame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
measure: Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)
timeFrame: participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks
measure: Global Status of Quality of Life (C-30,LC13 EORTC)
timeFrame: time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: National Cancer Institute of Mexico
state: Distrito Federal
Study officials:
affiliation: Mexico. Nacional Cancer Institute
name: Oscar G Arrieta, MD M Sc
role: PRINCIPAL_INVESTIGATOR
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