Trial Review

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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
Trial registered on ANZCTR


Registration number
ACTRN12625000456459
Ethics application status
Approved
Date submitted
29/04/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radioprotective effects of parthenolide lotion against skin injury caused by radiation in people with head and neck cancer
Scientific title
Radioprotective effects of parthenolide lotion against skin injury caused by radiation in people with head and neck cancer
Secondary ID [1] 313431 0
Nil
Universal Trial Number (UTN)
Trial acronym
REPAIR-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation induced dermatitis 335802 0
Head and Neck Cancer 335803 0
Condition category
Condition code
Skin 332380 332380 0 0
Dermatological conditions
Cancer 332381 332381 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both the intervention and control lotion are formulated with a base solution comprised of Coconut Water (from freeze-dried coconut powder); Hickory Bark Extract; Lactic Acid, Glycerin, Saccharide Isomerate, Jojoba & Esters.

Intervention: Base lotion with 1% parthenolide.
Rationale for parthenolide concentration: In vitro dosing of radiation in petri dishes has shown radiation protection of normal cells is achieved with 3 to 10 µM which equates to approximately 1% solution. In vivo experiments noted serum levels of 3 to 10 µM exposure was associated with benefit. Therefore the concentration of parthenolide will be 1%.
Amount to be applied: 8 pumps before and after radiation, applied in the radiation unit under supervision by a nurse.
Frequency of application: Twice daily (before and after radiation dose) for 6-7 weeks (depending on cycle length, all participants to receive >50Gy radiation to both sides of the neck/face)
NO changes to radiation dosing will be implemented by the study team. Changes are only permitted by the treating oncologist.
Adherence: Adherence is measured daily, with an adherence log completed by the nurse on duty to confirm application. If application is missed, a reason explaining why is documented.
Quality assurance: The lotion will be tested monthly to ensure parthenolide is stable in the lotion.

Randomisation of the lotion: The study is non-randomised, with all participants receiving BOTH the intervention and control lotion. The study is double blind, with the intervention and. control lotions labelled LEFT and RIGHT. Nobody in the study (with the exception of the unblinded monitor) knows which lotion is which. The LEFT is always applied to the LEFT side and the RIGHT lotion is always applied to the RIGHT side.
Intervention code [1] 329993 0
Prevention
Intervention code [2] 330988 0
Treatment: Other
Comparator / control treatment
Placebo lotion: The placebo lotion will be identical in composition to the parthenolife containing lotion, with the exception of the inclusion of parthenolide. This base lotion consists of coconut Water (from freeze-dried coconut powder), hickory bark extract, lactic acid, glycerin, saccharide Isomerate and Jojoba Esters. It is fragrance free.

All application details are identical to the active/intervention lotion.
Control group
Placebo

Outcomes
Primary outcome [1] 339935 0
Absolute radiation induced dermatitis severity
Timepoint [1] 339935 0
After 4 weeks of treatment
Primary outcome [2] 339936 0
Absolute RID severity
Timepoint [2] 339936 0
After 4 weeks of treatment
Secondary outcome [1] 441971 0
Incidence of severe RID
Timepoint [1] 441971 0
After 4 weeks of treatment
Secondary outcome [2] 441972 0
Incidence of severe RID
Timepoint [2] 441972 0
After each week of treatment (weeks 0 -7)
Secondary outcome [3] 441973 0
Average radiation induced dermatitis grade for full course of radiation therapy
Timepoint [3] 441973 0
After each week of treatment starting from week 4 through to week 7
Secondary outcome [4] 441977 0
Time until radiation induced dermatitis development
Timepoint [4] 441977 0
Assessed weekly until radiation induced dermatitis development from start of radiation
Secondary outcome [5] 441978 0
Rate of treatment-emergent adverse events (i.e. side effects associated with the intervention being tested)
Timepoint [5] 441978 0
Throughout treatment period (from beginning to week 6-7)
Secondary outcome [6] 441979 0
Adherence to IP
Timepoint [6] 441979 0
Assessed daily throughout treatment period
Secondary outcome [7] 441980 0
Participant preference
Timepoint [7] 441980 0
End of treatment period (week 6 or 7 of radiation therapy, depending on the cycle length)
Secondary outcome [8] 441981 0
Cumulative dose of radiation to each side of the head/neck
Timepoint [8] 441981 0
End of treatment period(week 6 or 7 of radiation therapy, depending on the cycle length)
Secondary outcome [9] 441984 0
Use of standard of care product(s) (Sorbolene/QV cream) on each side of the face
Timepoint [9] 441984 0
Assessed weekly throughout radiation therapy (6-7 weeks, depending on cycle length)

Eligibility
Key inclusion criteria
1. Adult (> or = to 18 years)
2. Diagnosed with locally advanced cancer of the head/neck
3. Scheduled to receive equal bilateral radiation + cisplatin/5FU (definitive or adjuvant)
4. Able to provide written informed consent and follow all clinical trial related procedures (translator to be provided for people of culturally and linguistically diverse (CALD) backgrounds)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ECOG score >1
2. Life expectancy <6 months as determined by treating clinician
3. Pregnant or lactating
4. History of dermatitis, psoriasis, allergies to any of the ingredients of the lotion or parthenolide or feverfew
5. Skin reaction to test doses of PTL lotion during screening
6. Involved in another trial that may compromise results/interpretation (decided as discretion of treating clinician)
7. Persistent wounds or pathologies related to prior surgery (decided at discretion of treating clinician)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Split body (face) design with participants serving as their own control. This means that one side of the neck/face receives the active lotion, and the other side receives the placebo lotion.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/03/2025
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
6/02/2026
Actual
Sample size
Target
10
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27346 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 43437 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317866 0
Charities/Societies/Foundations
Name [1] 317866 0
The James and Diana Ramsey Foundation
Country [1] 317866 0
Australia
Funding source category [2] 317867 0
University
Name [2] 317867 0
The University of Adelaide - SAiGENCI
Country [2] 317867 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network (CALHN)
Address
Country
Australia
Secondary sponsor category [1] 320198 0
None
Name [1] 320198 0
Address [1] 320198 0
Country [1] 320198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316545 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316545 0
Ethics committee country [1] 316545 0
Australia
Date submitted for ethics approval [1] 316545 0
19/11/2024
Approval date [1] 316545 0
03/12/2024
Ethics approval number [1] 316545 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138226 0
Dr Hannah Wardill
Address 138226 0
Level 5S, PCMT Theme, South Australian Health and Medical Research Institute (SAHMRI); North Terrace, Adelaide 5000 SA
Country 138226 0
Australia
Phone 138226 0
+61 476870643
Fax 138226 0
Email 138226 0
[email protected]
Contact person for public queries
Name 138227 0
Connor Williams
Address 138227 0
Level 5S, PCMT Theme, South Australian Health and Medical Research Institute (SAHMRI); North Terrace, Adelaide 5000 SA
Country 138227 0
Australia
Phone 138227 0
+61 400700596
Fax 138227 0
Email 138227 0
[email protected]
Contact person for scientific queries
Name 138228 0
Connor Williams
Address 138228 0
Level 5S, PCMT Theme, South Australian Health and Medical Research Institute (SAHMRI); North Terrace, Adelaide 5000 SA
Country 138228 0
Australia
Phone 138228 0
+61 400700596
Fax 138228 0
Email 138228 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.