Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12624000977572p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2024
Date registered
12/08/2024
Date last updated
12/08/2024
Date data sharing statement initially provided
12/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The Effect of Virgin Coconut Cream on Radiation Dermatitis and Quality of Life among Radiotherapy Cancer Patients
Query!
Scientific title
The Effect of Virgin Coconut Cream on Radiation Dermatitis and Quality of Life among Radiotherapy Cancer Patients: A Double-Blind Randomized Control Trial
Query!
Secondary ID [1]
312389
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Radiation Dermatitis
334194
0
Query!
Poor quality of life
334195
0
Query!
Condition category
Condition code
Cancer
330853
330853
0
0
Query!
Head and neck
Query!
Skin
331100
331100
0
0
Query!
Dermatological conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Intervention product: Virgin coconut cream
Dose: 15 g 2.5 Fingertips unit twice/day
Route/ mode: Topical
Duration: Until developing grade 3 radiation dermatitis or until complete radiotherapy treatment (6 weeks to 7 weeks)
Strategy to assess adherence to the interventions: Review participants medical record and weekly review
Query!
Intervention code [1]
328889
0
Prevention
Query!
Intervention code [2]
329087
0
Treatment: Drugs
Query!
Comparator / control treatment
Intervention product: Hydrocortisone Cream 1%
Dose: 15 g 2.5 Fingertips unit twice/day
Route/ mode: Topical
Duration: Until developing grade 3 radiation dermatitis or until complete radiotherapy treatment (6 weeks to 7 weeks)
Strategy to assess adherence to the interventions: Review participants medical record and weekly review
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
338619
0
Delaying grade 3 radiation dermatitis
Query!
Assessment method [1]
338619
0
Common Toxicity Criteria Adverse Event (CTCAE)
Query!
Timepoint [1]
338619
0
Baseline (Before starting radiotherapy), 5 fraction of radiotherapy, 10 fraction `of radiotherapy, 15 fraction of radiotherapy (primary timepoint), 20 fraction of radiotherapy, 25 fraction of radiotherapy, 30 fraction of radiotherapy, 35 fraction of radiotherapy
Query!
Primary outcome [2]
338865
0
Skin changes
Query!
Assessment method [2]
338865
0
Skin assessment by using CTCAE checklist
Query!
Timepoint [2]
338865
0
Baseline (Before starting radiotherapy), 5 doses of radiotherapy, 10 doses of radiotherapy, 15 doses of radiotherapy, 20 doses of radiotherapy, 25 doses of radiotherapy, 30 doses of radiotherapy, 35 dose of radiotherapy
Query!
Secondary outcome [1]
436673
0
Quality of Life
Query!
Assessment method [1]
436673
0
Dermatology Life Quality Index (DLQI)
Query!
Timepoint [1]
436673
0
Baseline (Before starting radiotherapy), 5 doses of radiotherapy, 10 doses of radiotherapy, 15 doses of radiotherapy, 20 doses of radiotherapy, 25 doses of radiotherapy, 30 doses of radiotherapy, 35 dose of radiotherapy (secondary timepoint)
Query!
Eligibility
Key inclusion criteria
Confirm diagnosis head and neck cancer, adjuvant and radical treatment, minimum dose radiation 55 Gy, No metastasis
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
60
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Language barrier, foreigner patient, have skin problem, allergic to virgin coconut and hydrocortisone product, uncontrolled diabetics
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization and allocation concealment will be conducted after receiving informed consent. The participant will be randomized by using block randomization (1:1). The researcher will identify from the radiographer the number of participants that will start radiotherapy treatment for each week for one month within the data collection period. Envelopes will be prepared according to the ratio for randomization and number of participants; Group A and Group B. Group labels will be placed into an envelope, along with a questionnaire and informed consent. The envelope will be distributed to the participants based on first come and first serve basis during recruitment.
Researchers will conduct this research along with medical officers and oncologist nurses to ensure participants will receive adequate monitoring. Product A will be provided by a local company and product B will be prepared by pharmacist Hospital Kuala Lumpur. Both products will be labelled by the pharmacist in charge which is provided by the researcher. To ensure double blind, intervention and control will be prepared in the same container and texture in order to prevent bias to the patient and researcher.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization of choosing a random envelope that will be given by the investigator by using a 1:1 ratio. Inside the envelope, will receive a card with the alphabet A and B. Participants will be grouped by using those cards.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
A total number of samples is 60 participants, which is divided into 30 control groups and 30 for intervention. This sample size is calculated by using RCT sample size formulae (proportion)
For weekly data, Repeated measure ANOVA will be used (Objective 2&4)
Descriptive (Frequency, Percentage) (Objective 1,3 & 4)
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/12/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
31/01/2025
Query!
Actual
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
26392
0
Malaysia
Query!
State/province [1]
26392
0
Kuala Lumpur
Query!
Funding & Sponsors
Funding source category [1]
316797
0
Self funded/Unfunded
Query!
Name [1]
316797
0
Query!
Address [1]
316797
0
Query!
Country [1]
316797
0
Query!
Primary sponsor type
Individual
Query!
Name
Nur Hidayah Awaludin - Universiti Teknologi Mara
Query!
Address
Query!
Country
Malaysia
Query!
Secondary sponsor category [1]
319019
0
Other
Query!
Name [1]
319019
0
University Teknologi MARA, UiTM Puncak Alam Campus
Query!
Address [1]
319019
0
Query!
Country [1]
319019
0
Malaysia
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
315566
0
National Medical Research Registry (NMRR)
Query!
Ethics committee address [1]
315566
0
03-3362 8205/8079/8898
Query!
Ethics committee country [1]
315566
0
Malaysia
Query!
Date submitted for ethics approval [1]
315566
0
20/06/2024
Query!
Approval date [1]
315566
0
Query!
Ethics approval number [1]
315566
0
Query!
Ethics committee name [2]
315567
0
Universiti Teknologi MARA, Faculty Research Ethics Committee
Query!
Ethics committee address [2]
315567
0
Faculty Health Science, University Teknologi MARA (UiTM) Puncak Alam Bandar Puncak Alam Campus, 42300 Puncak Alam, Selangor, Malaysia
Query!
Ethics committee country [2]
315567
0
Malaysia
Query!
Date submitted for ethics approval [2]
315567
0
14/06/2024
Query!
Approval date [2]
315567
0
Query!
Ethics approval number [2]
315567
0
Query!
Ethics committee name [3]
315827
0
University Malaya Medical Centre, Medical Research Ethics Committee (MREC)
Query!
Ethics committee address [3]
315827
0
University Malaya Medical Centre (UMMC), Lembah Pantai, 59100, Kuala Lumpur, MALAYSIA
Query!
Ethics committee country [3]
315827
0
Malaysia
Query!
Date submitted for ethics approval [3]
315827
0
29/07/2024
Query!
Approval date [3]
315827
0
Query!
Ethics approval number [3]
315827
0
Query!
Summary
Brief summary
This study will assess the effectiveness of an intervention on patient outcomes of the effect of virgin coconut cream on radiation dermatitis. Participants' information will remain confidential, and their involvement is voluntary. All data will be anonymized. The hypothesis is that the intervention will improve health outcomes.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
The research proposal and study materials will be compiled and submitted for approval by the Research Ethics Community (REC) UiTM and NMRR. The respondents' personal information will be confidential for samples, and they voluntarily participate in the study. The study population will be informed of the objectives and processes, and the collected data will be anonymized and kept confidential. Informed consent will be obtained through the Participant Inform Sheet (PIS), and participants may voluntarily participate or withdraw from the study at any time.
Query!
Contacts
Principal investigator
Name
135098
0
Mrs NUR HIDAYAH AWALUDIN
Query!
Address
135098
0
FACULTY HEALTH SCIENCE, UNIVERSIITI TEKNOLOGI MARA, PUNCAK ALAM CAMPUS, 42300 SELANGOR DARUL EHSAN, MALAYSIA
Query!
Country
135098
0
Malaysia
Query!
Phone
135098
0
+60173883864
Query!
Fax
135098
0
Query!
Email
135098
0
[email protected]
Query!
Contact person for public queries
Name
135099
0
NUR HIDAYAH AWALUDIN
Query!
Address
135099
0
FACULTY HEALTH SCIENCE, UNIVERSIITI TEKNOLOGI MARA, PUNCAK ALAM CAMPUS, 42300 SELANGOR DARUL EHSAN, MALAYSIA
Query!
Country
135099
0
Malaysia
Query!
Phone
135099
0
+60173883864
Query!
Fax
135099
0
Query!
Email
135099
0
[email protected]
Query!
Contact person for scientific queries
Name
135100
0
NUR HIDAYAH AWALUDIN
Query!
Address
135100
0
FACULTY HEALTH SCIENCE, UNIVERSIITI TEKNOLOGI MARA, PUNCAK ALAM CAMPUS, 42300 SELANGOR DARUL EHSAN, MALAYSIA
Query!
Country
135100
0
Malaysia
Query!
Phone
135100
0
+60173883864
Query!
Fax
135100
0
Query!
Email
135100
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF