Nutritional Assessment of Patients With Non-small Cell Lung Cancer Treated With Osimertinib

NCT07559526 | Completed DMC

• 1 other identifier: NUTRI-CPNM
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small-cell Lung Cancer; Sarcopenia; Quality of Life

Keywords

non-small-cell lung cancer; osimertinib; malnutrition; body composition; doselimiting toxicities; sarcopenia; dynapenia

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (3)

• Diagnosis of malnutrition

  Day 0, During the consultation

• Sarcopenia detection and diagnosis

  Day 0, During the consultation

• Quality of Life of the patients

  Day 0, During the consultation

Study Arms (1)

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

Interventions

Unic group OTHER

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.

Unic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead
• Complejo Hospitalario Universitario de Vigo: collaborator

Study Sites (1)

University Hospital Complex of Vigo

Vigo, Pontevedra, 36312, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Claudia Barca Díez

  Galicia Sur Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: March 20, 2024
• Primary Completion: May 24, 2024
• Study Completion: July 12, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

ES (1)