Cancer-related MalnutritionNCT07059598
Relationship of Nutritional Status to Chemotherapy Treatment Completion and Outcomes in Cancer Patients
An observational study of Cancer-related Malnutrition, run by Abbott Nutrition at 13 sites in Turkey (Türkiye).
Trial summary
This non-interventional, prospective, non-drug observational study is designed to observe the effect of the nutritional status of metastatic and non-metastatic gastric, colon and lung cancer patients on their cancer chemotherapy treatment completion rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Malnutrition
- How many people
- 209 participants
- Where
- 13 sitesTurkey (Türkiye)
- Study dates
- 12 Aug 2022to 1 Mar 2025
- 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: Medical Oncology Clinics
Who may be able to join
- Subject or subject's legally acceptable representative (LAR) has voluntarily signed and dated an ICF approved by an IEC, or any other applicable privacy authorization prior to any participation in the study.
- Ambulatory and inpatient subject.
- Subject recently (within the last month) or newly diagnosed to have metastatic or non-metastatic gastric, colon and lung cancer.
- Subject is recently receiving chemotherapy or recently prescribed to begin chemotherapy treatment per standard of care (within the last month) or candidates who will receive chemotherapy.
- Subject has a life expectancy greater than 6 months.
Who cannot join
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, any other psychological condition, serious illness or medical condition that may interfere with study completion.
- Subject has malignant tumors other than treated DCIS, fully treated non-melanoma skin cancer, curatively resected in-situ cervical cancer or other curative treated tumors (except stomach, colon and lung cancer) for > 5 years.
- Subject has bone marrow metastasis.
- Subject is lactating.
- Subject is participating in another study that has not been approved as a concomitant study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Turkey (Türkiye)13 sites
Hacettepe Üniversitesi Tıp Fakültesi Onkoloji Hastanesi
Altındağ, Ankara
Akdeniz Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi
Antalya
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Battalgazi, Malatya
Ege Üniversitesi Hastanesi Sağlık Uygulama ve Araştırma Merkezi
Bornova, İzmir
S.B. İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştırma Hastanesi
Kadıköy, Istanbul
Bursa Uludağ Üniversitesi Tıp Fakültesi Hastanesi Sağlık Uygulama ve Araştırma Hastanesi
Ortahisar, Bursa
Karadeniz Teknik Üniversitesi Farabi Hastanesi
Ortahisar, Trabzon
Çukurova Üniversitesi Balcalı Hastanesi Sağlık Uygulama ve Araştırma Hastanesi
Sarıçam, Adana
İstanbul Maslak Acıbadem Hastanesi
Sarıyer, Istanbul
Amerikan Hastanesi
Şişli, Istanbul
Dicle Ünversitesi Hastaneleri Tıp Fakültesi Hastanesi
Sur, Diyarbakır
Ankara Etlik Şehir Hastanesi
Yenimahalle, Ankara
Sağlık Bilimleri Üniversitesi Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim Ve Araştırma Hastanesi
Yenimahalle, Ankara
About this study
Official title: Evaluate the Relationship of Nutritional Status to Chemotherapy Treatment Completion Rates and Outcomes in Real-life Conditions in Patients With Metastatic and Non-metastatic Gastric, Colon, and Lung Cancer.
This non-interventional, prospective, non-drug observational study is designed to observe the effect of the nutritional status of metastatic and non-metastatic gastric, colon and lung cancer patients on their cancer chemotherapy treatment completion rates.
- Conditions
- Cancer-related Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
RMAPP
A tool to screen patients for risk of malnutrition and/or sarcopenia
Measured: Baseline to week 24
PG-SGA
Healthcare Professional completed assessment resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
Measured: Baseline to week 24
Secondary outcomes (8)
Weight
Change in weight
Measured: Baseline to 24 weeks
Height
Height in CM
Measured: Baseline
Calf Circumference
Change in calf circumference
Measured: Baseline to 24 weeks
Fat Free Mass Index
Evaluate Muscle Mass in relation to height and weight
Measured: Baseline to week 24
EORTC QLQ-C30
Questionnaire with 28 questions from 1 to 4 with higher number is more favorable and 2 overall score questions from very poor to excellent
Measured: Baseline to 12 months
Body Mass Index
As calculated from height and weight
Measured: Baseline to week 24
Handgrip Strength
Change in handgrip dynamometer as measured in kilograms
Measured: Baseline to 24 weeks
Walking Speed
Change in Gait Speed over 6 meter walk
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start12 Aug 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related MalnutritionStudies 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059598
- Sponsor's protocol ID
- DA28
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Relationship of Nutritional Status to Chemotherapy Treatment Completion Rates and Outcomes in Real-life Conditions in Patients With Metastatic and Non-metastatic Gastric, Colon, and Lung Cancer.
- ClinicalTrials.gov ID
- NCT07059598
- Acronym / sponsor ID
- DA28
- Conditions
- Cancer-related Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 11 Jul 2025 (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.
This non-interventional, prospective, non-drug observational study is designed to observe the effect of the nutritional status of metastatic and non-metastatic gastric, colon and lung cancer patients on their cancer chemotherapy treatment completion rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Oncology Clinics
Key inclusion criteria (5 listed)
- Subject or subject's legally acceptable representative (LAR) has voluntarily signed and dated an ICF approved by an IEC, or any other applicable privacy authorization prior to any participation in the study.
- Ambulatory and inpatient subject.
- Subject recently (within the last month) or newly diagnosed to have metastatic or non-metastatic gastric, colon and lung cancer.
- Subject is recently receiving chemotherapy or recently prescribed to begin chemotherapy treatment per standard of care (within the last month) or candidates who will receive chemotherapy.
- Subject has a life expectancy greater than 6 months.
Key exclusion criteria (5 listed)
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, any other psychological condition, serious illness or medical condition that may interfere with study completion.
- Subject has malignant tumors other than treated DCIS, fully treated non-melanoma skin cancer, curatively resected in-situ cervical cancer or other curative treated tumors (except stomach, colon and lung cancer) for > 5 years.
- Subject has bone marrow metastasis.
- Subject is lactating.
- Subject is participating in another study that has not been approved as a concomitant study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RMAPP
Time frame: Baseline to week 24
A tool to screen patients for risk of malnutrition and/or sarcopenia
PG-SGA
Time frame: Baseline to week 24
Healthcare Professional completed assessment resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
8 secondary outcomes
Weight
Time frame: Baseline to 24 weeks
Height
Time frame: Baseline
Calf Circumference
Time frame: Baseline to 24 weeks
Fat Free Mass Index
Time frame: Baseline to week 24
EORTC QLQ-C30
Time frame: Baseline to 12 months
Body Mass Index
Time frame: Baseline to week 24
Handgrip Strength
Time frame: Baseline to 24 weeks
Walking Speed
Time frame: Baseline to 24 weeks
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 11 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Malnutrition, run by Abbott Nutrition at 13 sites in Turkey (Türkiye).
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 5 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Turkey (Türkiye). 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?
RMAPP (time frame: Baseline to week 24). The study lists 2 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 11 Jul 2025.