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

Completed

• Conditions: Cancer-related Malnutrition

• Registration Number: NCT07059598
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-12
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RMAPP	Baseline to week 24	A tool to screen patients for risk of malnutrition and/or sarcopenia
PG-SGA	Baseline to week 24	Healthcare Professional completed assessment resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished

Secondary Outcome Measures

Name	Time	Method
Weight	Baseline to 24 weeks	Change in weight
Height	Baseline	Height in CM
Calf Circumference	Baseline to 24 weeks	Change in calf circumference
Fat Free Mass Index	Baseline to week 24	Evaluate Muscle Mass in relation to height and weight
EORTC QLQ-C30	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
Body Mass Index	Baseline to week 24	As calculated from height and weight
Handgrip Strength	Baseline to 24 weeks	Change in handgrip dynamometer as measured in kilograms
Walking Speed	Baseline to 24 weeks	Change in Gait Speed over 6 meter walk

Trial Locations

Locations (13)

Çukurova Üniversitesi Balcalı Hastanesi Sağlık Uygulama ve Araştırma Hastanesi; 🇹🇷 Sarıçam, Adana, Turkey

Hacettepe Üniversitesi Tıp Fakültesi Onkoloji Hastanesi; 🇹🇷 Altındağ, Ankara, Turkey

Ankara Etlik Şehir Hastanesi; 🇹🇷 Yenimahalle, Ankara, Turkey

Sağlık Bilimleri Üniversitesi Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim Ve Araştırma Hastanesi; 🇹🇷 Yenimahalle, Ankara, Turkey

Bursa Uludağ Üniversitesi Tıp Fakültesi Hastanesi Sağlık Uygulama ve Araştırma Hastanesi; 🇹🇷 Ortahisar, Bursa, Turkey

Dicle Ünversitesi Hastaneleri Tıp Fakültesi Hastanesi; 🇹🇷 Sur, Diyarbakir, Turkey

S.B. İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştırma Hastanesi; 🇹🇷 Kadıköy, Istanbul, Turkey

İstanbul Maslak Acıbadem Hastanesi; 🇹🇷 Sarıyer, Istanbul, Turkey

Amerikan Hastanesi; 🇹🇷 Şişli, Istanbul, Turkey

Ege Üniversitesi Hastanesi Sağlık Uygulama ve Araştırma Merkezi; 🇹🇷 Bornova, Izmir, Turkey

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