Neoplasms

All Conditions

Nervous System Diseases

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sarcoma

Liposarcoma

Histiocytoma, Malignant Fibrous

Fibrosarcoma

Leiomyosarcoma

Rhabdomyosarcoma

Sarcoma, Synovial

Nerve Sheath Neoplasms

Neurofibrosarcoma

Liposarcoma, Myxoid

Histiocytic Sarcoma

Lymphangiosarcoma

Myosarcoma

Histiocytoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplasms, Fibrous Tissue

Neurofibromatoses

Neurofibroma

Histiocytic Disorders, Malignant

Histiocytosis

Lymphatic Diseases

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Embryonal Sarcoma

Myxoid Liposarcoma

Neurofibromatosis

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Ifosfamide

Isophosphamide mustard

Mesna

1xAI (doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm) + 5x5 Gy radiotherapy + 2xAI + surgery

Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm with prophylactic mesna), one before radiotherapy and two within the gap between radiotherapy and surgery.

Sequential chemotherapy - 3 courses of AI

Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with a daily image guidance with cone beam-CT-based position verification.

Hypofractionated radiotherapy

After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI), body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the first course of chemotherapy - doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm (AI regimen) with prophylactic mesna. Then a patient will be irradiated 5x5 Gy and after radiotherapy he or she will receive two courses of AI within 4-6 weeks, depending on the tolerance. Then the response analysis in DWI-MRI and toxicity assessment and will be performed. On the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability, a patient will be referred to surgery.

There is lack of standard treatment of marginally resectable sarcomas. Results of commonly used approaches are unsatisfactory. The addition of neoadjuvant/induction chemotherapy before the irradiation and in the prolonged gap between the end of hypofractionated 5x5 Gy radiotherapy and surgery may allow to obtain the R0 resection rate, high pathological response rate and/or a higher rate of limb-sparing/conservative surgery as well as to increase patients' survival.

Hypofractionation represents a variation of radiotherapy fractionation in which the total dose is divided into fewer fractions with an increased fraction dose. Such treatment may lead to additional biological effects when compared to conventionally fractionated radiotherapy (eg. vascular damage, increased immunogenicity, and antigenicity). The main advantages of hypofractionation are those related to the decreased overall treatment time what is more convenient for both patients and physicians, increased compliance and makes the treatment more cost-effective. Intriguing, such an approach may provide an additional benefit when treating non-radiosensitive tumors with a low alpha/beta ratio (eg. sarcomas).

The basis of the study was a trial conducted by Kosela et al. in our center, which showed that preoperative short 5x5 Gy radiotherapy with immediate surgery is an effective and well-tolerated treatment of resectable sarcomas of extremities or trunk wall.

The rationale of chemotherapy comes from the interim analysis of a multicenter, international EORTC study comparing neoadjuvant systemic approaches in high-risk sarcomas. It was proven that AI regimen, which consists of ifosfamide and anthracyclines allowed to obtain 20% benefit in relapse-free survival and overall survival as compared to pathologically-tailored chemotherapy.

Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall

Hypofractionated 5x5 Gy Radiotherapy With Sequential Doxorubicin and Ifosfamide-based Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall

HIF-1 (hypoxia-inducible factor 1) - marker of hypoxia, predicting tumor response on radiotherapy; CD105/CD31/VEGF-A - tumor microvessel density; CD14, CD163, CD68KP i CD68 PG-M1 - tumor associated macrophages.

Radiological assessment of tumor change, especially diffusion parameters in DWI-MRI 6 weeks after the end of irradiation, according to the EORTC criteria.

The study will be stopped prematurely if the rate of non-hematological toxicity grade 3 \>30%

Maria Sklodowska-Curie National Research Institute of Oncology

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Dysgeusia

Taste Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Sensation Disorders

Neurologic Manifestations

Small Cell Lung Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

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

Oscar G Arrieta, MD M Sc

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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

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

We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes

fat mass and lean body mass pre-post chemotherapy

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

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).

energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

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.

comparison of patients who increased or decreased their sensibility to the PT of umami taste

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.

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.

Instituto Nacional de Cancerologia de Mexico

Head Of the Thoracic Oncology Clinic. SNI II

Serious and/or Other \[non-serious\] adverse events were not collected/assessed for this observational study

any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational

LUNG CANCER PATIENTS

Pre-chemotherapy Patientes =40

Age, Continuous

Sex: Female, Male

Mexico

Region of Enrollment

We invited to participate 72 patients with NSCLC newly diagnosed, but only 40 patients 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.

No analysis of serum zinc was performed and a small number of subjects analyzed.

Dr. Oscar Arrieta

For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.

Pre-chemotherapy Patientes

Post-chemotherapy Patients

Dysgeusia (UMAMI Perception)

we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy

we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy

FAT MASS (kg)

LEAN BODY MASS (kg)

BODY COMPOSITION

Body Mass Index

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).

SGA A

SGA B & C

Subjective Global Assessment pre-chemotherapy

Subjective Global Assessment post chemotherapy

Post-chemotherapy Patientes

Subjective Global Assessment

protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapy

animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

proteins

animal proteins

patient with more sensibility to perceive sweet taste from food

≥ Sweet Perception Thresholds After Chemotherapy

patient with less sensibility to perceive sweet taste from food

< Sweet Perception Thresholds After Chemotherapy

PROTEIN AND FAT Consumption

IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy

IRON CONSUMPTION \< Sweet perception thresholds after chemotherapy

IRON Consumption

Dysgeusia (UMAMI Recognition)

change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire

change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire

change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire

change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire

change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire

change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire

Global status

Role functioning

Emotional functioning

Fatigue

Appetite loss

Constipation

HRQL Pre-chemotherapy

HRQL Post-chemotherapy

Quality o f Life

patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(\> UPT) = more sensibility to umami perception

> or = Umami Perception Thresholds

patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(\< UPT) = less sensibility to umami perception

< Umami Perception Thresholds

Change From Baseline in Albumin After 2 Cycles of Chemotherapy

change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire

peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(\> UPT) = more sensibility to umami perception

peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.

(\< UPT) = less sensibility to umami perception

Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)

change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire

quality of life scales in patient with more or the same sensibility to recognize the umami taste

< or = Umami Recognition Thresholds

> Umami Recognition Thresholds

Global Status of Quality of Life (C-30,LC13 EORTC)

Dysgeusia (SWEET Perception)

Dysgeusia (SWEET Recognition)

Dysgeusia (BITTER Perception)

Dysgeusia (BITTER Recognition)

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.

UMAMI 0.3 - 1.5 μmol/ml

UMAMI > 1.5 μmol/ml

Dysgeusia (UMAMI Dilutions Dichotomized)

SWEET 3.5 - 9.5 μmol/ml

SWEET > 9.5 μmol/ml

patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy

patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy

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

Dysgeusia (SWEET Dilutions Dichotomized)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall	NCT03651375	Sarcoma Fibrosarcoma Leiomyosarcoma Liposarcoma Myosarcoma Histiocytic Sar... Synovial Sarcom... Lymphangiosarco... Malignant Perip... Myxofibrosarcom... Myxoid Liposarc... Undifferentiate... Pleomorphic Lip... Undifferentiate... Dedifferentiate... Pleomorphic Rha... Malignant Trito...	Sequential chem... Hypofractionate...	18 Years - 100 Years	Maria Sklodowska-Curie National Research Institute of Oncology
Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer	NCT01540045	Non-Small Cell ... Dysgeusia Taste Disorders Lung Neoplasms Small Cell Lung...		18 Years - 90 Years	Instituto Nacional de Cancerologia de Mexico
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy	NCT00380965	Peripheral Neur... Antineoplastic ...	Cesamet™ (nabil...	18 Years - 75 Years	NEMA Research, Inc.
Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy	NCT02953184	Antineoplastic ...	Pegylated Lipos... Cyclophosphamid... Taxotere Dexrazoxane (DZ... vitamin B Doxorubicin Breast Conserve... Modified Radica... Sentinel Lymph ...	18 Years - 70 Years	Jilin University
Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer	NCT01540045	Non-Small Cell ... Dysgeusia Taste Disorders Lung Neoplasms Small Cell Lung...		18 Years - 90 Years	Instituto Nacional de Cancerologia de Mexico
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall	NCT03651375	Sarcoma Fibrosarcoma Leiomyosarcoma Liposarcoma Myosarcoma Histiocytic Sar... Synovial Sarcom... Lymphangiosarco... Malignant Perip... Myxofibrosarcom... Myxoid Liposarc... Undifferentiate... Pleomorphic Lip... Undifferentiate... Dedifferentiate... Pleomorphic Rha... Malignant Trito...	Sequential chem... Hypofractionate...	18 Years - 100 Years	Maria Sklodowska-Curie National Research Institute of Oncology

Spots Global Cancer Trial Database for antineoplastic combined chemotherapy protocols