ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy

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

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Dietary supplement: oral nutrition supplement

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

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alshaimaa Rabie; Phone Number: 01061263030; Email: alshaimaa.ph@o6u.edu.eg

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Recruiting
    • Beni Suef University Hospital
    • Contact: Alshaimaa Ibrahim Rabie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
Experimental: Group B; nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and	Dietary supplement: oral nutrition supplement; patients receive ONS 300kcal in daily basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory data values mean and standard deviation	Albumin and CRP ,total protein	3 months
overall response rate	complete response or progression and regression percentage of participants	6 months
common adverse effects	Git toxicity , hematologic toxicity	6 months

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Alshaimaa Rabie, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 22, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: FMBSUREC/09072023/Rabie

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No