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Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients


N/A
18 Years
90 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer, Dysgeusia, Taste Disorders, Lung Neoplasms, Small Cell Lung Carcinoma

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Trial Information

Effect of Chemotherapy With Paclitaxel and Cisplatin on Development Dysgeusia in Non-small Cell Lung Cancer Patients


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

dysgeusia

Outcome Description:

describe the threshold of perception and recognition of 3 basic tastes (sweet, bitter and umami) with 5 dilutions with different concentrations

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Oscar G Arrieta, MD M Sc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mexico. Nacional Cancer Institute

Authority:

Mexico: Ethics Committee

Study ID:

ECPCDLC2012

NCT ID:

NCT01540045

Start Date:

December 2010

Completion Date:

May 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Dysgeusia
  • Taste Disorders
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Non-Small Cell Lung Cancer
  • Dysgeusia
  • Antineoplastic Combined Chemotherapy Protocols
  • Paclitaxel
  • Cisplatin
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Dysgeusia
  • Lung Neoplasms
  • Taste Disorders
  • Small Cell Lung Carcinoma

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