NCT07850778

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

5 years

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Oral Nutritional SupplementationColon Cancer

Keywords

colon canceroral nutritional supplementsadherence to ONSadjuvant chemotherapydietitian follow-up

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    From ONS prescription to approximately 3 months after prescription.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

osmaniye korkut ata üniversitesi KARACAOĞLAN YERLEŞKESİ D blok sağlık bilimleri fakültesi 1. kat oda no:101

Merkez, Osmaniye, 80000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 37410217RESULT

  • Lidoriki 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.

    PMID: 37946396RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

January 1, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)