Oral Nutritional SupplementationONS COLON CANCT07850778
ONS USE IN COLON CANCER
An observational study of Oral Nutritional Supplementation and Colon Cancer, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational cohort study examined oral nutritional supplement (ONS) use and associated factors in patients receiving adjuvant mFOLFOX6 chemotherapy after curative surgery for stage III colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Nutritional Supplementation, Colon Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 209 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2026
- 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: Adults with histopathologically confirmed stage III colon adenocarcinoma who underwent curative surgery, received adjuvant mFOLFOX6 chemotherapy, and were prescribed ONS at Osmaniye Training and Research Hospital between January 2021 and January 2026.
Who may be able to join
- Age 18 years or older.
- Histopathologically confirmed stage III colon adenocarcinoma according to the eighth edition of the AJCC TNM classification.
- Previous curative surgery for colon cancer.
- Receipt of adjuvant mFOLFOX6 chemotherapy.
- Prescription of oral nutritional supplements (ONS) during adjuvant chemotherapy.
- At least three months of clinical and Nutrition Outpatient Clinic follow-up.
- Complete medical and nutritional records for the variables required for analys
Who cannot join
- Pregnancy or postpartum status.
- Receipt of neoadjuvant or palliative treatment.
- Receipt of chemotherapy regimens other than mFOLFOX6.
- Active second malignancy.
- Dementia or a history of cerebrovascular disease.
- Dysphagia, previous upper gastrointestinal surgery, or food allergy precluding safe ONS use.
Show all 10Show fewer
- Additional major surgery performed during colectomy.
- Preoperative ONS use.
- ONS usage that could not be assessed from available records.
- Missing follow-up information or analytical data.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
osmaniye korkut ata üniversitesi KARACAOĞLAN YERLEŞKESİ D blok sağlık bilimleri fakültesi 1. kat oda no:101
Merkez, Osmaniye, 80000
About this study
Official title: USE OF PRESCRİBED ORAL NUTRİTİONAL SUPPLEMENTS DURİNG ADJUVANT CHEMOTHERAPY İN STAGE III COLON CANCER AND ASSOCİATED FACTORS: A SİNGLE-CENTER RETROSPECTİVE COHORT STUDY
This retrospective observational cohort study examined oral nutritional supplement (ONS) use and associated factors in patients receiving adjuvant mFOLFOX6 chemotherapy after curative surgery for stage III colon cancer. Medical and routine nutrition follow-up records from Osmaniye Training and Research Hospital between January 2021 and January 2026 were reviewed. The study included 362 patients prescribed ONS. The main outcomes were ONS non-initiation or early discontinuation and failure to meet a study-defined consumption criterion among ONS users. Demographic, clinical, nutritional, and psychosocial factors associated with these outcomes were evaluated.
Read the detailed description
Oral nutritional supplements (ONS) are prescribed to support nutritional intake when patients cannot meet their requirements through regular foods. However, prescribed supplements may not be initiated or consumed in the recommended amounts and duration. This single-center retrospective cohort study evaluated ONS consumption patterns and associated factors in adults with stage III colon adenocarcinoma receiving adjuvant mFOLFOX6 chemotherapy after curative surgery.
Data were obtained from electronic medical records, operative and pathology reports, oncology records, and routine Nutrition Outpatient Clinic forms for patients followed between January 2021 and January 2026. Eligible patients were aged 18 years or older, had been prescribed ONS during adjuvant chemotherapy, and had at least three months of clinical and nutritional follow-up with complete analytical data. No research-specific intervention or additional patient contact occurred.
Patients who never initiated ONS or used them for fewer than 7 days were classified as ONS non-users/early discontinuers. Patients who used ONS for at least 7 days were classified as ONS users. Among users, consumption of at least 75% of the recommended daily amount for at least 4 weeks was defined as meeting the study-specific consumption criterion. Consumption was assessed using patient-reported intake documented in routine follow-up records over approximately three months after prescription. Objective container counts or electronic consumption monitoring were not performed.
Recorded variables included demographic characteristics, living arrangements, comorbidities, surgical characteristics, postoperative complications, body mass index, Prognostic Nutritional Index, Nutritional Risk Screening 2002 scores, and Beck Depression Inventory scores. Reasons for ONS non-use, symptoms reported during ONS use, and attendance at dietitian follow-up visits were also evaluated.
Exploratory logistic regression analyses examined factors associated with non-initiation/early discontinuation among all eligible patients and failure to meet the consumption criterion among ONS users. Associations were interpreted as observational and did not establish causality.
- Conditions
- Oral Nutritional Supplementation, Colon Cancer
- Keywords
- colon cancer, oral nutritional supplements, adherence to ONS, adjuvant chemotherapy, dietitian follow-up
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ONS Non-Users/Early Discontinuers | Patients with stage III colon cancer who were prescribed oral nutritional supplements (ONS) during adjuvant mFOLFOX6 chemotherapy after curative surgery but never initiated ONS or used them for fewer than 7 days, based on patient-reported consumption documented in routine nutrition follow-up records. | |
| ONS Users | Patients with stage III colon cancer who were prescribed oral nutritional supplements (ONS) during adjuvant mFOLFOX6 chemotherapy after curative surgery and used them for at least 7 days, based on patient-reported consumption documented in routine nutrition follow-up records. These patients were further classified according to whether they consumed at least 75% of the recommended daily amount for at least 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Oral Nutritional Supplement Non-Initiation or Early
Percentage of patients prescribed oral nutritional supplements (ONS) who never initiated use or used ONS for fewer than 7 days. The denominator includes all eligible patients prescribed ONS. Usage status was determined retrospectively from patient-reported consumption documented in routine nutrition follow-up records.
Measured: From ONS prescription to approximately 3 months after prescription.
Percentage of Patients With Oral Nutritional Supplement Non-Initiation or Early Discontinuation
Percentage of patients prescribed oral nutritional supplements (ONS) who never initiated use or used ONS for fewer than 7 days. The denominator includes all eligible patients prescribed ONS. Usage status was determined retrospectively from patient-reported consumption documented in routine nutrition follow-up records.
Measured: From ONS prescription to approximately 3 months after prescription.
Percentage of ONS Users Not Meeting the Study-Defined Consumption Criterion
Percentage of patients using oral nutritional supplements (ONS) for at least 7 days who did not meet the study-defined consumption criterion of consuming at least 75% of the recommended daily amount for at least 4 weeks. Failure to meet either threshold was classified as not meeting the criterion. The denominator includes patients who used ONS for at least 7 days. Consumption was assessed retrospectively using patient-reported intake documented in routine nutrition follow-up records.
Measured: From ONS prescription to approximately 3 months after prescription.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2021
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral Nutritional SupplementationStudies 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
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYBALA TAZEOGLU, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850778
- Sponsor's protocol ID
- 06.08.2026-41340
- Acronym
- ONS COLON CA
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. This retrospective study used patient medical and nutritional follow-up records containing sensitive health information. Only aggregate study results will be disseminated to protect participant privacy and confidentiality.
Publications
Pi JF, Zhou J, Lu LL, Li L, Mao CR, Jiang L. A study on the effect of nutrition education based on the goal attainment theory on oral nutritional supplementation after colorectal cancer surgery. Support Care Cancer. 2023 Jul 6;31(7):444. doi: 10.1007/s00520-023-07905-1.
PubMed 37410217Lidoriki I, Frountzas M, Karanikki E, Katsarlinou E, Tsikrikou I, Toutouzas KG, Schizas D. Adherence to Oral Nutrition Supplementation in Gastrointestinal Cancer Patients: A Systematic Review of the Literature. Nutr Cancer. 2024;76(1):31-41. doi: 10.1080/01635581.2023.2277519. Epub 2023 Dec 27.
PubMed 37946396
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USE OF PRESCRİBED ORAL NUTRİTİONAL SUPPLEMENTS DURİNG ADJUVANT CHEMOTHERAPY İN STAGE III COLON CANCER AND ASSOCİATED FACTORS: A SİNGLE-CENTER RETROSPECTİVE COHORT STUDY
- ClinicalTrials.gov ID
- NCT07850778
- Acronym / sponsor ID
- ONS COLON CA / 06.08.2026-41340
- Conditions
- Oral Nutritional Supplementation, Colon Cancer
- Keywords
- colon cancer, oral nutritional supplements, adherence to ONS, adjuvant chemotherapy, dietitian follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 30 Sep 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.
This retrospective observational cohort study examined oral nutritional supplement (ONS) use and associated factors in patients receiving adjuvant mFOLFOX6 chemotherapy after curative surgery for stage III colon cancer. Medical and routine nutrition follow-up records from Osmaniye Training and Research Hospital between January 2021 and January 2026 were reviewed. The study included 362 patients prescribed ONS. The main outcomes were ONS non-initiation or early discontinuation and failure to meet a study-defined consumption criterion among ONS users. Demographic, clinical, nutritional, and psychosocial factors associated with these outcomes were evaluated.
Detailed description
Oral nutritional supplements (ONS) are prescribed to support nutritional intake when patients cannot meet their requirements through regular foods. However, prescribed supplements may not be initiated or consumed in the recommended amounts and duration. This single-center retrospective cohort study evaluated ONS consumption patterns and associated factors in adults with stage III colon adenocarcinoma receiving adjuvant mFOLFOX6 chemotherapy after curative surgery.
Data were obtained from electronic medical records, operative and pathology reports, oncology records, and routine Nutrition Outpatient Clinic forms for patients followed between January 2021 and January 2026. Eligible patients were aged 18 years or older, had been prescribed ONS during adjuvant chemotherapy, and had at least three months of clinical and nutritional follow-up with complete analytical data. No research-specific intervention or additional patient contact occurred.
Patients who never initiated ONS or used them for fewer than 7 days were classified as ONS non-users/early discontinuers. Patients who used ONS for at least 7 days were classified as ONS users. Among users, consumption of at least 75% of the recommended daily amount for at least 4 weeks was defined as meeting the study-specific consumption criterion. Consumption was assessed using patient-reported intake documented in routine follow-up records over approximately three months after prescription. Objective container counts or electronic consumption monitoring were not performed.
Recorded variables included demographic characteristics, living arrangements, comorbidities, surgical characteristics, postoperative complications, body mass index, Prognostic Nutritional Index, Nutritional Risk Screening 2002 scores, and Beck Depression Inventory scores. Reasons for ONS non-use, symptoms reported during ONS use, and attendance at dietitian follow-up visits were also evaluated.
Exploratory logistic regression analyses examined factors associated with non-initiation/early discontinuation among all eligible patients and failure to meet the consumption criterion among ONS users. Associations were interpreted as observational and did not establish causality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS Non-Users/Early Discontinuers | – | –Patients with stage III colon cancer who were prescribed oral nutritional supplements (ONS) during adjuvant mFOLFOX6 chemotherapy after curative surgery but never initiated ONS or used them for fewer than 7 days, based on patient-reported consumption documented in routine nutrition follow-up records. |
| ONS Users | – | –Patients with stage III colon cancer who were prescribed oral nutritional supplements (ONS) during adjuvant mFOLFOX6 chemotherapy after curative surgery and used them for at least 7 days, based on patient-reported consumption documented in routine nutrition follow-up records. These patients were further classified according to whether they consumed at least 75% of the recommended daily amount for at least 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with histopathologically confirmed stage III colon adenocarcinoma who underwent curative surgery, received adjuvant mFOLFOX6 chemotherapy, and were prescribed ONS at Osmaniye Training and Research Hospital between January 2021 and January 2026.
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Histopathologically confirmed stage III colon adenocarcinoma according to the eighth edition of the AJCC TNM classification.
- Previous curative surgery for colon cancer.
- Receipt of adjuvant mFOLFOX6 chemotherapy.
- Prescription of oral nutritional supplements (ONS) during adjuvant chemotherapy.
Key exclusion criteria (10 listed)
- Pregnancy or postpartum status.
- Receipt of neoadjuvant or palliative treatment.
- Receipt of chemotherapy regimens other than mFOLFOX6.
- Active second malignancy.
- Dementia or a history of cerebrovascular disease.
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
Percentage of Patients With Oral Nutritional Supplement Non-Initiation or Early
Time frame: From ONS prescription to approximately 3 months after prescription.
Percentage of patients prescribed oral nutritional supplements (ONS) who never initiated use or used ONS for fewer than 7 days. The denominator includes all eligible patients prescribed ONS. Usage status was determined retrospectively from patient-reported consumption documented in routine nutrition follow-up records.
Percentage of Patients With Oral Nutritional Supplement Non-Initiation or Early Discontinuation
Time frame: From ONS prescription to approximately 3 months after prescription.
Percentage of patients prescribed oral nutritional supplements (ONS) who never initiated use or used ONS for fewer than 7 days. The denominator includes all eligible patients prescribed ONS. Usage status was determined retrospectively from patient-reported consumption documented in routine nutrition follow-up records.
Percentage of ONS Users Not Meeting the Study-Defined Consumption Criterion
Time frame: From ONS prescription to approximately 3 months after prescription.
Percentage of patients using oral nutritional supplements (ONS) for at least 7 days who did not meet the study-defined consumption criterion of consuming at least 75% of the recommended daily amount for at least 4 weeks. Failure to meet either threshold was classified as not meeting the criterion. The denominator includes patients who used ONS for at least 7 days. Consumption was assessed retrospectively using patient-reported intake documented in routine nutrition follow-up records.
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 Sep 2026.
- Results publication: PubMed 37410217Pi JF, Zhou J, Lu LL, Li L, Mao CR, Jiang L. A study on the effect of nutrition education based on the goal attainment theory on oral nutritional supplementation after colorectal cancer surgery. Support Care Cancer. 2023 Jul 6;31(7):444. doi: 10.1007/s00520-023-07905-1.
- Results publication: PubMed 37946396Lidoriki I, Frountzas M, Karanikki E, Katsarlinou E, Tsikrikou I, Toutouzas KG, Schizas D. Adherence to Oral Nutrition Supplementation in Gastrointestinal Cancer Patients: A Systematic Review of the Literature. Nutr Cancer. 2024;76(1):31-41. doi: 10.1080/01635581.2023.2277519. Epub 2023 Dec 27.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This retrospective study used patient medical and nutritional follow-up records containing sensitive health information. Only aggregate study results will be disseminated to protect participant privacy and confidentiality.
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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.
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 Oral Nutritional Supplementation and Colon Cancer, run by Osmaniye Korkut Ata University at 1 site 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 7 inclusion and 10 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 Sep 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 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?
Percentage of Patients With Oral Nutritional Supplement Non-Initiation or Early (time frame: From ONS prescription to approximately 3 months after prescription.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07850778, which also lists 2 linked publications.
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 Sep 2026.