ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Dietary Supplement: oral nutrition supplement

• Registration Number: NCT05980624
• Lead Sponsor: Beni-Suef University

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

Study Timeline

• Study Start: 2023-07-20
• Study First Submitted: 2023-07-22
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	oral nutrition supplement	nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and

Primary Outcome Measures

Name	Time	Method
Body Composition	3 month	measured by DEXA OR BIA
Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)	3 MONTHS	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
Anthropometric measures	3 month	Body mass index change

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beni suef university hospital; 🇪🇬 Banī Suwayf, Egypt