The Nutritional Status of Chemo-radiotherapy Patients

Completed

• Conditions: Cancer; Malnutrition

• Registration Number: NCT01937273
• Lead Sponsor: Charles Darwin University

Brief Summary

Cancer patients are one of the patient groups at highest risk for the development of malnutrition. Anti-cancer treatments, such as chemotherapy and radiotherapy, can further heighten the risk due to the nutrition-related toxicities experienced during this time.

This study aims to baseline the nutritional status of chemo-radiotherapy patients undergoing treatment at the Alan Walker Cancer Care Centre (Darwin), identify contributors to nutritional deterioration and determine if there is a difference between Indigenous and non-Indigenous patients.

Detailed Description

Background: Cancer patients are at a greater risk of malnutrition. Limited data exists on the development of malnutrition during chemo - radiotherapy, particularly in rural and remote areas of Australia. Additionally, there is no data on the nutritional status of cancer patients in the Northern Territory or areas with a high proportion of Indigenous Australians. While considering the aforementioned dearth of literature, we are conducting a study in Darwin, Northern Territory of Australia. This study aims to establish a baseline of the nutritional status of chemo - radiotherapy patients undergoing treatment at the Alan Walker Cancer Care Centre (Darwin), to identify contributing factors to nutritional deterioration, and to determine if there is a difference between Indigenous and non-Indigenous patients. This study will provide a prospective analysis of malnutrition and a clear insight of nutritional status of cancer patients. It presents the first of its kind to address the nutritional status of cancer patients in Indigenous Australians.

Methods/ design: Using the Patient Generated-Subjective Global Assessment; all eligible patients will be assessed for malnutrition and consented for participation into this study. Each participant's nutritional status will be assessed at baseline, first week of treatment, final week of treatment, and at one month post treatment. Prevalence data will be analysed using percentages. Comparative data will be analysed using chi-square tests. A linear regression analysis of the results will be undertaken. Data will be analysed using SPSS version 20 (IBM SPSS).

Discussion: Weight loss and malnutrition among cancer patient is well documented, however, results from our study might appear to be more remarkable when compared with the other published data, because of our participants demographic, assessment tool used: the Patient Generated-Subjective Global Assessment has not been validated for use in Indigenous Australian Keywords: Nutritional status, malnutrition, prospective analysis, chemo-radiotherapy

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years or over undergoing curative intent chemo-radiotherapy at AWCCC
• Able to speak basic English or have an interpreter present
• Able to provide consent

Exclusion Criteria

• Pregnant or breast feeding women
• Non-English speaking background where interpreter not available
• Change to single modality treatment (ie change from chemo-radiotherapy to chemotherapy or radiotherapy alone) or change to treatment intent (ie change from curative intent to palliative intent)
• Violent or aggressive patients to maintain the safety of investigators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of malnutrition amongst chemo-radiotherapy patients	1 year

Secondary Outcome Measures

Name	Time	Method
The incidence of the development of malnutrition during chemo-radiotherapy	1 year

Trial Locations

Locations (1)

Alan Walker Cancer Care Centre; 🇦🇺 Darwin, Northern Territory, Australia