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OpenTrials
Completed

NCT Number: NCT07059598

Relationship of Nutritional Status to Chemotherapy Treatment Completion and Outcomes in Cancer Patients

This non-interventional, prospective, non-drug observational study is designed to observe the effect of the nutritional status of metastatic and non-metastatic gastric, colon and lung cancer patients on their cancer chemotherapy treatment completion rates.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Çukurova Üniversitesi Balcalı Hastanesi Sağlık Uygulama ve Araştırma Hastanesi, Sarıçam, Adana, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject or subject's legally acceptable representative (LAR) has voluntarily signed and dated an ICF approved by an IEC, or any other applicable privacy authorization prior to any participation in the study.
  • Ambulatory and inpatient subject.
  • Subject recently (within the last month) or newly diagnosed to have metastatic or non-metastatic gastric, colon and lung cancer.
  • Subject is recently receiving chemotherapy or recently prescribed to begin chemotherapy treatment per standard of care (within the last month) or candidates who will receive chemotherapy.
  • Subject has a life expectancy greater than 6 months.

Exclusion criteria

  • Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, any other psychological condition, serious illness or medical condition that may interfere with study completion.
  • Subject has malignant tumors other than treated DCIS, fully treated non-melanoma skin cancer, curatively resected in-situ cervical cancer or other curative treated tumors (except stomach, colon and lung cancer) for > 5 years.
  • Subject has bone marrow metastasis.
  • Subject is lactating.
  • Subject is participating in another study that has not been approved as a concomitant study.

Treatment and study plan

Primary outcomes

  1. RMAPP

    Time frame: Baseline to week 24

    A tool to screen patients for risk of malnutrition and/or sarcopenia

  2. PG-SGA

    Time frame: Baseline to week 24

    Healthcare Professional completed assessment resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished

Secondary outcomes

  1. Weight

    Time frame: Baseline to 24 weeks

    Change in weight

  2. Height

    Time frame: Baseline

    Height in CM

  3. Calf Circumference

    Time frame: Baseline to 24 weeks

    Change in calf circumference

  4. Fat Free Mass Index

    Time frame: Baseline to week 24

    Evaluate Muscle Mass in relation to height and weight

  5. EORTC QLQ-C30

    Time frame: Baseline to 12 months

    Questionnaire with 28 questions from 1 to 4 with higher number is more favorable and 2 overall score questions from very poor to excellent

  6. Body Mass Index

    Time frame: Baseline to week 24

    As calculated from height and weight

  7. Handgrip Strength

    Time frame: Baseline to 24 weeks

    Change in handgrip dynamometer as measured in kilograms

  8. Walking Speed

    Time frame: Baseline to 24 weeks

    Change in Gait Speed over 6 meter walk

Other outcomes

  1. HealthCare Resource Utilization

    Time frame: Baseline to 12 months

    Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Evaluate the Relationship of Nutritional Status to Chemotherapy Treatment Completion Rates and Outcomes in Real-life Conditions in Patients With Metastatic and Non-metastatic Gastric, Colon, and Lung Cancer.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 11, 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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