NCT01937273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

August 29, 2013

Last Update Submit

July 15, 2020

Conditions

Keywords

Nutritional status, malnutrition, chemo-radiotherapy

Outcome Measures

Primary Outcomes (1)

  • The prevalence of malnutrition amongst chemo-radiotherapy patients

    1 year

Secondary Outcomes (1)

  • The incidence of the development of malnutrition during chemo-radiotherapy

    1 year

Other Outcomes (2)

  • Factors contributing to the development of malnutrition

    1 year

  • The difference between Indigenous and non-Indigenous in respect to their nutritional status

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (18 years or over) who are being treated with curative intent chemo-radiotherapy at the Alan Walker Cancer Care Centre during the data collection period

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alan Walker Cancer Care Centre

Darwin, Northern Territory, 0810, Australia

Location

MeSH Terms

Conditions

MalnutritionNeoplasms

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Loise Moodie

    Royal Darwin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 9, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations