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PANSOCRP: The Nutritional Status of Chemo-radiotherapy Patients

Sponsor
Charles Darwin University (Other)
Overall Status
Completed
CT.gov ID
NCT01937273
Collaborator
(none)
50
Enrollment
1
Location
30
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Analysis of the Nutritional Status of Chemo-radiotherapy Patients
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. The prevalence of malnutrition amongst chemo-radiotherapy patients [1 year]

    Secondary Outcome Measures

    1. The incidence of the development of malnutrition during chemo-radiotherapy [1 year]

    Other Outcome Measures

    1. Factors contributing to the development of malnutrition [1 year]

    2. The difference between Indigenous and non-Indigenous in respect to their nutritional status [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alan Walker Cancer Care Centre Darwin Northern Territory Australia 0810

    Sponsors and Collaborators

    • Charles Darwin University

    Investigators

    • Principal Investigator: Loise Moodie, Royal Darwin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles Darwin University
    ClinicalTrials.gov Identifier:
    NCT01937273
    Other Study ID Numbers:
    • HREC2013 1973
    First Posted:
    Sep 9, 2013
    Last Update Posted:
    Jul 16, 2020
    Last Verified:
    Jul 1, 2020
    Keywords provided by Charles Darwin University
    Nutritional status, malnutrition, chemo-radiotherapy
    Additional relevant MeSH terms:
    Malnutrition

    Study Results

    No Results Posted as of Jul 16, 2020