Non-small-cell Lung CancerNUTRI-CPNMNCT07559526
Nutritional Assessment of Patients With Non-small Cell Lung Cancer Treated With Osimertinib
An observational study of Non-small-cell Lung Cancer and Sarcopenia, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer, Sarcopenia, Quality of Life
- What is being tested?
- Unic group
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2024to 12 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Unic group
- Keywords
- non-small-cell lung cancer, osimertinib, malnutrition, body composition, doselimiting toxicities, sarcopenia, dynapenia
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unic groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Unic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender
Patient gender (Female, Male)
Measured: Day 0, During the consultation
Age
Patient age in years
Measured: 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).
Measured: Day 0, During the consultation
Start date of Osimertinib treatment
Date of initiation of osimertinib therapy as recorded in the medical record.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 0, During the consultation
Usual body weight
Self-reported usual body weight prior to disease or treatment, measured in kilograms (kg).
Measured: 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
Measured: Day 0, During the consultation
Food intake recall
Dietary intake assessed 24-hour food recall, including total caloric and macronutrient intake.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, During the consultation
Secondary outcomes (3)
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 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.
Measured: 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.
Measured: 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.
Measured: Day 0, During the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start20 Mar 2024
- Primary completion24 May 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Vigo
- Responsible party
- Sponsor
- Investigators
- Claudia Barca Díez, Principal investigator, Galicia Sur Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559526
- Sponsor's protocol ID
- NUTRI-CPNM
- Acronym
- NUTRI-CPNM
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment of Patients With Non-small Cell Lung Cancer Treated With Osimertinib
- ClinicalTrials.gov ID
- NCT07559526
- Acronym / sponsor ID
- NUTRI-CPNM / NUTRI-CPNM
- Conditions
- Non-small-cell Lung Cancer, Sarcopenia, Quality of Life
- Keywords
- non-small-cell lung cancer, osimertinib, malnutrition, body composition, doselimiting toxicities, sarcopenia, dynapenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Vigo
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unic group | – | Other: Unic groupPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Revocation of consent to participate in the study by the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unic groupTo 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. | Other | Unic group |
Primary outcome
Gender
Time frame: Day 0, During the consultation
Patient gender (Female, Male)
Age
Time frame: Day 0, During the consultation
Patient age in years
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).
Start date of Osimertinib treatment
Time frame: Day 0, During the consultation
Date of initiation of osimertinib therapy as recorded in the medical record.
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.
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.
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.
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.
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.
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.
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).
Usual body weight
Time frame: Day 0, During the consultation
Self-reported usual body weight prior to disease or treatment, measured in kilograms (kg).
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
Food intake recall
Time frame: Day 0, During the consultation
Dietary intake assessed 24-hour food recall, including total caloric and macronutrient intake.
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.
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.
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.
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.
3 secondary outcomes
Diagnosis of malnutrition
Time frame: Day 0, During the consultation
Sarcopenia detection and diagnosis
Time frame: Day 0, During the consultation
Quality of Life of the patients
Time frame: Day 0, During the consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Barca Díez principal investigator
Galicia Sur Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small-cell Lung Cancer and Sarcopenia, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender (time frame: Day 0, During the consultation). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.