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Completed

NCT Number: NCT07559526

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Gender

    Time frame: Day 0, During the consultation

    Patient gender (Female, Male)

  2. Age

    Time frame: Day 0, During the consultation

    Patient age in years

  3. Stage of NSCLC

    Time frame: Day 0, During the consultation

    Non-Small Cell Lung Cancer (NSCLC) is staged from 0 to IV based on tumor size (T), lymph node involvement (N), and metastasis (M).

  4. Start date of Osimertinib treatment

    Time frame: Day 0, During the consultation

    Date of initiation of osimertinib therapy as recorded in the medical record.

  5. Initial and current osimertinib dose

    Time frame: Day 0, During the consultation

    Dose of osimertinib in milligrams (mg/day) at treatment initiation and at the time of assessment.

  6. Total duration of osimertinib treatment

    Time frame: Day 0, During the consultation

    Total duration of osimertinib therapy calculated from treatment initiation to discontinuation or last follow-up, expressed in days.

  7. Dose-limiting toxicities (DLTs)

    Time frame: Day 0, During the consultation

    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.

  8. Body weight

    Time frame: Day 0, During the consultation

    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.

  9. Height

    Time frame: Day 0, During the consultation

    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.

  10. Calf circumference

    Time frame: Day 0, During the consultation

    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.

  11. Body mass index (BMI)

    Time frame: Day 0, During the consultation

    Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).

  12. Usual body weight

    Time frame: Day 0, During the consultation

    Self-reported usual body weight prior to disease or treatment, measured in kilograms (kg).

  13. Weight loss during treatment

    Time frame: Day 0, During the consultation

    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

  14. Food intake recall

    Time frame: Day 0, During the consultation

    Dietary intake assessed 24-hour food recall, including total caloric and macronutrient intake.

  15. Fat mass (FM) by bioimpedance

    Time frame: Day 0, During the consultation

    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.

  16. Lean body mass (LBM) by bioimpedance

    Time frame: Day 0, During the consultation

    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.

  17. Lean body mass index (LBMI)

    Time frame: Day 0, During the consultation

    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.

  18. Muscle functionality

    Time frame: Day 0, During the consultation

    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.

Secondary outcomes

  1. Diagnosis of malnutrition

    Time frame: Day 0, During the consultation

    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 than

    1 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.

  2. Sarcopenia detection and diagnosis

    Time frame: Day 0, During the consultation

    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.

  3. Quality of Life of the patients

    Time frame: Day 0, During the consultation

    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.

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Collaborators

  • Complejo Hospitalario Universitario de Vigo

Registry information

Acronym: NUTRI-CPNM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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