Clinical trial NCT05980624: ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Official title: The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

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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

Primary outcomes:
measure: Body Composition
timeFrame: 3 month
measure: Anthropometric measures
timeFrame: 3 month
measure: Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: 3 MONTHS
Secondary outcomes:
measure: Laboratory data values mean and standard deviation
timeFrame: 3 months
measure: overall response rate
timeFrame: 6 months
measure: common adverse effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni suef university hospital
Study officials:
affiliation: Beni-Suef University
name: Alshaimaa Rabie
role: PRINCIPAL_INVESTIGATOR
References: