ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

NCT05980624 | Completed Phase 2

• 1 other identifier: FMBSUREC/09072023/Rabie
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve health state quality of life and increase chemotherapy tolerance

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (3)

• Body Composition

  measured by DEXA OR BIA

  3 month

• Anthropometric measures

  Body mass index change

  3 month

• Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)

  malnutrition assessment tool. ( 0-1 )No intervention required at this time. Re-assessment on routine and regular basis during treatment. (2-3) Patient \& family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate. (4-8) Requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms . * 9 Indicates a critical need for improved symptom management and/or nutrient intervention options

  3 MONTHS

Secondary Outcomes (3)

• Laboratory data values mean and standard deviation

  3 months

• overall response rate

  6 months

• common adverse effects

  6 months

Study Arms (2)

Group A

NO INTERVENTION

nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months

Group B

EXPERIMENTAL

nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and

Dietary Supplement: oral nutrition supplement

Interventions

oral nutrition supplement DIETARY_SUPPLEMENT

patients receive ONS 300kcal in daily basis

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GI cancer patients will be included in the study if they meet the following criteria:
• Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.
• Age above 18 years old
• Be accessible for chemotherapy treatment and follow-up
• Availability to administer oral supplements
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
• Life expectancy ≥3 months.
• Written informed consent according to the local Ethics Committee requirements
• Willing to fill Nutrition questionnaires.

You may not qualify if:

• The patients will be excluded from the study if they have the following criteria:
• Known hypersensitivity reaction to the investigational compounds or incorporated substances
• patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism)
• Pregnancy or lactating
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
• Age \< 18 years
• Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni suef university hospital

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Alshaimaa Rabie

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nutrition pharmacist

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: August 8, 2023
• Study Start: July 20, 2023
• Primary Completion: November 30, 2024
• Study Completion: January 16, 2025
• Last Updated: September 19, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)