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

NCT07059598 | Completed

• 1 other identifier: DA28
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Cancer-related Malnutrition

Outcome Measures

Primary Outcomes (2)

• RMAPP

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

  Baseline to week 24

• PG-SGA

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

  Baseline to week 24

Secondary Outcomes (8)

• Weight

  Baseline to 24 weeks

• Height

  Baseline

• Calf Circumference

  Baseline to 24 weeks

• Fat Free Mass Index

  Baseline to week 24

• EORTC QLQ-C30

  Baseline to 12 months

Other Outcomes (1)

• HealthCare Resource Utilization

  Baseline to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical Oncology Clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (13)

Çukurova Üniversitesi Balcalı Hastanesi Sağlık Uygulama ve Araştırma Hastanesi

Sarıçam, Adana, Turkey (Türkiye)

Location

Hacettepe Üniversitesi Tıp Fakültesi Onkoloji Hastanesi

Altındağ, Ankara, Turkey (Türkiye)

Location

Ankara Etlik Şehir Hastanesi

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Sağlık Bilimleri Üniversitesi Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim Ve Araştırma Hastanesi

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Bursa Uludağ Üniversitesi Tıp Fakültesi Hastanesi Sağlık Uygulama ve Araştırma Hastanesi

Ortahisar, Bursa, Turkey (Türkiye)

Location

Dicle Ünversitesi Hastaneleri Tıp Fakültesi Hastanesi

Sur, Diyarbakır, Turkey (Türkiye)

Location

S.B. İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştırma Hastanesi

Kadıköy, Istanbul, Turkey (Türkiye)

Location

İstanbul Maslak Acıbadem Hastanesi

Sarıyer, Istanbul, Turkey (Türkiye)

Location

Amerikan Hastanesi

Şişli, Istanbul, Turkey (Türkiye)

Location

Ege Üniversitesi Hastanesi Sağlık Uygulama ve Araştırma Merkezi

Bornova, İzmir, Turkey (Türkiye)

Location

İnönü Üniversitesi Turgut Özal Tıp Merkezi

Battalgazi, Malatya, Turkey (Türkiye)

Location

Karadeniz Teknik Üniversitesi Farabi Hastanesi

Ortahisar, Trabzon, Turkey (Türkiye)

Location

Akdeniz Üniversitesi Sağlık Araştırma ve Uygulama Merkezi Hastanesi

Antalya, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 11, 2025
• Study Start: August 12, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (13)