Nutritional Assessment of Patients With Non-small Cell Lung Cancer Treated With Osimertinib (NUTRI-CPNM)

Nutritional assessment of patients with non-small cell lung cancer treated with osimertinib.

Non-small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases and is a leading cause of morbidity and mortality worldwide. Between 35% and 65% of NSCLC patients experience nutritional problems or malnutrition, which significantly affects their prognosis and quality of life. This study aims to describe the nutritional status and body composition of NSCLC patients treated with osimertinib, an oral tyrosine kinase inhibitor, while also assessing the prevalence of sarcopenia, presarcopenia, and dynapenia. Additionally, we explore the relationship between dose-limiting toxicities (DLTs) and nutritional status, as well as the impact of nutritional status on quality of life using the EQ-5D scale.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sarcopenia; Non-small-cell Lung Cancer
• Intervention / Treatment: Other: Unic group

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • University Hospital Complex of Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with NSCLC undergoing treatment with osimertinib in the Vigo Health Area, who receive pharmaceutical care in the Outpatient Clinics of the Pharmacy Service of the Álvaro Cunqueiro Hospital.

Description

Inclusion Criteria:

• Patients over 18 years of age.
• Patients diagnosed with NSCLC.
• Patients undergoing osimertinib treatment who collect their medication at the Pharmacy Outpatient Clinic of the Álvaro Cunqueiro Hospital.
• Patients who have consented to participate by signing the informed consent form.

Exclusion Criteria:

• Patients who have discontinued osimertinib treatment.
• Patients currently receiving osimertinib treatment for an indication other than those authorized in the product information (compassionate use).
• Patients who do not sign the informed consent form.

Withdrawal criteria:

- Revocation of consent to participate in the study by the patient.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Unic group; Patients diagnosed with NSCLC undergoing treatment with osimertinib in the Vigo Health Area, who receive pharmaceutical care in the Outpatient Clinics of the Pharmacy Service of the Álvaro Cunqueiro Hospital.

Other: Unic group; To describe the nutritional status and body composition of patients diagnosed with non-melanoma skin cancer (NMSC) treated with osimertinib in the Vigo health area. To evaluate the prevalence of sarcopenia in the study patients. To observe if there is a relationship between low muscle mass or malnutrition and the development of delayed-type hyperplasia (DTH) during osimertinib treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Patient gender (Female, Male)	Day 0, During the consultation
Age	Patient age in years	Day 0, During the consultation
Stage of NSCLC	Non-Small Cell Lung Cancer (NSCLC) is staged from 0 to IV based on tumor size (T), lymph node involvement (N), and metastasis (M).	Day 0, During the consultation
Start date of Osimertinib treatment	Date of initiation of osimertinib therapy as recorded in the medical record.	Day 0, During the consultation
Initial and current osimertinib dose	Dose of osimertinib in milligrams (mg/day) at treatment initiation and at the time of assessment.	Day 0, During the consultation
Total duration of osimertinib treatment	Total duration of osimertinib therapy calculated from treatment initiation to discontinuation or last follow-up, expressed in days.	Day 0, During the consultation
Dose-limiting toxicities (DLTs)	Incidence and type of dose-limiting toxicities experienced during osimertinib treatment, graded according to CTCAE criteria. The most common DLTs included diarrhea, mucositis, folliculitis, nausea, thrombocytopenia, paronychia, and elevated transaminases.	Day 0, During the consultation
Body weight	Body weight measured in kilograms (kg). The tools used for anthropometric data collection included a weighing scale with an integrated stadiometer (Asimed® brand, manufactured by Sibelmed, Barcelona, Spain) and an anthropometric measuring tape.	Day 0, During the consultation
Height	Height measured in meters (m). The tools used for anthropometric data collection included a weighing scale with an integrated stadiometer (Asimed® brand, manufactured by Sibelmed, Barcelona, Spain) and an anthropometric measuring tape.	Day 0, During the consultation
Calf circumference	Calf circumference measured in centimeters (cm) at the point of maximum circumference. The tools used for anthropometric data collection included a weighing scale with an integrated stadiometer (Asimed® brand, manufactured by Sibelmed, Barcelona, Spain) and an anthropometric measuring tape.	Day 0, During the consultation
Body mass index (BMI)	Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).	Day 0, During the consultation
Usual body weight	Self-reported usual body weight prior to disease or treatment, measured in kilograms (kg).	Day 0, During the consultation
Weight loss during treatment	Percentage and absolute change in body weight from baseline during osimertinib treatment. It was calculated using the following formula: %WL = [(usual weight - current weight)/usual weight] × 100	Day 0, During the consultation
Food intake recall	Dietary intake assessed 24-hour food recall, including total caloric and macronutrient intake.	Day 0, During the consultation
Fat mass (FM) by bioimpedance	Fat mass measured in kilograms using bioelectrical impedance analysis (BIA) the InBody S10® body composition analyzer (manufactured by InBody Co., Ltd., Seoul, Republic of Korea), was used, which is a device that measures impedance using 6 frequencies (1, 5, 50, 250, 500, and 1000 kHz) for each of the 5 body segments: right arm, left arm, trunk, right leg, and left leg. The measurements were performed with patients standing barefoot, with their legs apart and arms not touching the torso. The 8-point tactile electrodes were placed on the thumb and middle finger of each hand and on both ankles. The data obtained were analyzed using the LookinBody 120® software.	Day 0, During the consultation
Lean body mass (LBM) by bioimpedance	Lean body mass measured in kilograms using bioelectrical impedance analysis (BIA) the InBody S10® body composition analyzer (manufactured by InBody Co., Ltd., Seoul, Republic of Korea), was used, which is a device that measures impedance using 6 frequencies (1, 5, 50, 250, 500, and 1000 kHz) for each of the 5 body segments: right arm, left arm, trunk, right leg, and left leg. The measurements were performed with patients standing barefoot, with their legs apart and arms not touching the torso. The 8-point tactile electrodes were placed on the thumb and middle finger of each hand and on both ankles. The data obtained were analyzed using the LookinBody 120® software.	Day 0, During the consultation
Lean body mass index (LBMI)	Lean body mass index calculated as lean body mass divided by height squared (kg/m²). A reduced muscle mass was considered for LBMI < 17 kg/m2 in men and <15 kg/m2 in women. Using bioelectrical impedance analysis (BIA) the InBody S10® body composition analyzer (manufactured by InBody Co., Ltd., Seoul, Republic of Korea), was used, which is a device that measures impedance using 6 frequencies (1, 5, 50, 250, 500, and 1000 kHz) for each of the 5 body segments: right arm, left arm, trunk, right leg, and left leg. The measurements were performed with patients standing barefoot, with their legs apart and arms not touching the torso. The 8-point tactile electrodes were placed on the thumb and middle finger of each hand and on both ankles. The data obtained were analyzed using the LookinBody 120® software.	Day 0, During the consultation
Muscle functionality	Muscle functionality was assessed through hand grip strength using a hydraulic dynamometer (Jamar®, manufactured by Performance Health, Warrenville, IL, USA), providing the strength of the dominant arm (kg). Three measurements were taken with the subject seated and without arm support, with a 60 s rest between each measurement to prevent muscle fatigue. Dynapenia or reduced strength was considered if the value was <27 kg in men and <16 kg in women.	Day 0, During the consultation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of malnutrition	Following GLIM criteria (Global Leadership Initiative on Malnutrition): Phenotypic Criteria: Involuntary weight loss: >5% in the last 6 months or >10% in more than 6 months.; Low BMI: <20 kg/m2 if <70 years or <22 kg/m2 if ≥70 years.; Muscle mass evaluation: assessed by LBMI (BIA) or by CC if BIA was not performed.; Etiological Criteria:; Reduced food intake or absorption: ≤50% of energy requirements for more than1 week, any reduction for more than 2 weeks, or any chronic gastrointestinal condition negatively affecting food absorption or assimilation.; Inflammation or acute/chronic disease: the presence of inflammatory conditions or chronic diseases affecting nutritional status. The combination of at least one phenotypic criterion and one etiological criterion enabled the diagnosis of malnutrition. The etiological criterion of inflammation, required for the diagnosis of malnutrition, was met in all study patients as they were diagnosed with NSCLC.	Day 0, During the consultation
Sarcopenia detection and diagnosis	Applying the EWGSOP2 algorithm proposed by the European Working Group on Sarcopenia in Older People (EWGSOP). The screening was performed using the Strength, Assistance walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire, and a score of 4 or higher was considered to indicate a risk of sarcopenia. Muscle strength was determined by dynamometry, and BIA or CC assessed muscle mass. Patients with low muscle strength were classified as dynapenic; presarcopenia was diagnosed in patients showing reduced muscle mass and no significant decrease in muscle strength; finally, sarcopenia was diagnosed in patients who, in addition to low hand grip strength, also exhibited a reduction in muscle mass.	Day 0, During the consultation
Quality of Life of the patients	It was assessed using the EQ-5D scale, a standardized tool that measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Additionally, patients completed a visual Analog scale (VAS) ranging from 0 to 100, reflecting their general health status.	Day 0, During the consultation

Collaborators and Investigators

• Sponsor: Fundacin Biomedica Galicia Sur
• Collaborators: Complejo Hospitalario Universitario de Vigo
• Investigators: Principal Investigator: Claudia Barca Díez, Galicia Sur Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: body composition; sarcopenia; malnutrition; osimertinib; dynapenia; non-small-cell lung cancer; doselimiting toxicities
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Carcinoma, Non-Small-Cell Lung; Sarcopenia
• Other Study ID Numbers: NUTRI-CPNM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No