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OpenTrials
Completed

NCT Number: NCT05980624

ONS 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beni suef university hospital

Banī Suwayf, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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.
  • 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:
  • 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

Treatment and study plan

Oral Nutrition supplement

Dietary Supplement

patients receive ONS 300kcal in daily basis

Primary outcomes

  1. Body Composition

    Time frame: 3 month

    measured by DEXA OR BIA

  2. Anthropometric measures

    Time frame: 3 month

    Body mass index change

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

    Time frame: 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

Secondary outcomes

  1. Laboratory data values mean and standard deviation

    Time frame: 3 months

    Albumin and CRP ,total protein

  2. overall response rate

    Time frame: 6 months

    complete response or progression and regression percentage of participants

  3. common adverse effects

    Time frame: 6 months

    Git toxicity , hematologic toxicity

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 8, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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