ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

NCT ID: NCT05980624

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2025-01-16

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

Detailed Description

Malnutrition is a major public health issue in low- and middle-income countries and forms part of the United Nations 2030 Agenda for Sustainable Development Goals .Cancer is a systemic disease, since even in the early stages malignancies are accompanied by homeostatic imbalance, including metabolic deregulation and increased catabolism. These abnormalities may initially seem poorly discernible in the clinic, but with disease progression they may aggravate; and may cause overt cancer-related cachexia.GI cancers show higher mortality than any other kind of cancer. In 2020, they accounted for an estimated 3.5 million deaths worldwide, with a further 5.0 million new cases diagnosed in the same year . Colorectal cancer (CRC) is the most common type of GI cancer, being the third most common of all organ cancers after lung and breast cancers, whereas gastric, liver, esophageal, and pancreatic cancers are ranked the fifth, sixth, eighth, and 12th most commonly diagnosed cancers, respectively

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B

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

Group Type: EXPERIMENTAL

oral nutrition supplement

Intervention Type: DIETARY_SUPPLEMENT

patients receive ONS 300kcal in daily basis

Interventions

oral nutrition supplement

patients receive ONS 300kcal in daily basis

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

-

GI cancer patients will be included in the study if they meet the following criteria:

1. Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.

2. Age above 18 years old

3. Be accessible for chemotherapy treatment and follow-up

4. Availability to administer oral supplements

5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2

6. Life expectancy ≥3 months.

7. Written informed consent according to the local Ethics Committee requirements

8. Willing to fill Nutrition questionnaires.

9. Negative pregnancy test for pre-menopausal women before inclusion in the trial

Exclusion Criteria

• The patients will be excluded from the study if they have the following criteria:

1. Known hypersensitivity reaction to the investigational compounds or incorporated substances

2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism)

3. Pregnancy or lactating

4. 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

5. Age < 18 years

6. Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

ALshaimaa Ibrahim Rabie

Clinical nutrition pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alshaimaa Rabie

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Beni suef university hospital

Banī Suwayf, , Egypt

Countries

Egypt

Other Identifiers

FMBSUREC/09072023/Rabie

Identifier Type: -

Identifier Source: org_study_id