Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000177550
Ethics application status
Approved
Date submitted
19/01/2024
Date registered
23/02/2024
Date last updated
24/03/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Electro-Magnetic-Frequency Therapy (EMF) for Cancer
Scientific title
Effect of Electro-Magnetic-Frequency Therapy (EMF) on Circulating Tumour Cell (CTC) count in cancer patients
Secondary ID [1] 311369 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 332639 0
Condition category
Condition code
Cancer 329343 329343 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electro-Magnetic-Frequency Therapy (EMF) consists of a suite of low frequency waves (<25x10^6 Hz) – lower than those emitted by mobile phones (1x10^8 Hz) – specific to the cancer.
We will use the EMF device Spooky2 plus Phanotron plasma bulb or plasma tube, and a suite of frequencies specific to the patient's illness as per EMF/Rife catalogue ranging between 1 Hz to 3.5 MHz..
EMF therapy is adminstered by a EMF trained nurse, who will also monitor adherence to the therapy.
EMF waves are transmitted through the air whilst the patient is sitting closely (~10 cm-100cm) to the frequency emitting plasma tube. EMF sessions are typically of 60-90 min length, during which the patient can undertake some stationary relaxing activities, e.g. reading, writing, meditating, without using an electronic device

A one-off EMF therapy session is scheduled initally, and treatment effectiveness assessed by 2x blood tests before and after the session.
The patient will then discuss with their health practitioner a treatment program of 12 week duration, e.g. twice weekly sessions for 12 weeks.
Intervention code [1] 327811 0
Treatment: Devices
Comparator / control treatment
Primary comparator: Patients are their own control. Treatment eff ectiveness will be assessed by Circulating Tumour Cell (CTC) count by blood test before and after treatment.
Control group
Active

Outcomes
Primary outcome [1] 337168 0
Number of CTC by cytology
Timepoint [1] 337168 0
Day 2, 3 months, 6 months post-commencement of treatment compared to baseline (Day1 before the treatment)
Secondary outcome [1] 430958 0
tumour markers, e.g. CA-125 for ovarian cancer, CA-19-9 for pancreatic cancer
Timepoint [1] 430958 0
3 months and 6 months post-commencement of treatment compared to baseline (within 4 weeks before first treatment)
Secondary outcome [2] 430959 0
tumour size
Timepoint [2] 430959 0
6 months after first treatment compared to baseline (most recent before treatment as available)
Secondary outcome [3] 430960 0
number of tumour sites/ metastasis
Timepoint [3] 430960 0
6 months after first treatment compared to baseline (most recent before treatment as available)
Secondary outcome [4] 430961 0
Quality of life
Timepoint [4] 430961 0
3 and 6 months post-commencement of treatment compared to baseline (before treatment Day 1)

Eligibility
Key inclusion criteria
adults diagnosed with cancer
at any stage of their cancer treatment, including
patients undergoing active cancer treatment, and patients in remission as determined by pathology testing following completion of cancer treatment;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with electronic implants, e.g. pacemaker, defibrillator, cochlear implant, ring-shaped metals in the body
planning to introduce new treatments during the study period
unable to commit to regular treatment sessions over a 3 month period
unable to give consent

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
a. As this study has a pre-post design, patients will be their own control, and CTC counts on day 2, at 3 and 6 month will be compared to their baseline (before EMF treatment). As CTC count is reported in nCTC/ml, comparison will be simple subtraction, and changes in CTC count will be reported numerically and as percentage.
b. CTC results will be compared qualitatively to clinical outcome, including scans, and tumour marker levels. A lower (higher) CTC count is usually associated with a lower (higher) probability of cancer growth / status.
c. We will use the statistical program SPSS to analyse the change in Quality of Life and Symptom Impact scores at 3 and 6 months compared to baseline. Continuous data will be analysed using the t-test, and ANCOVA test, and categorical data will be analysed using the Chi-square and Kruskal-Wallis Test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 41897 0
3122 - Hawthorn
Recruitment postcode(s) [2] 41898 0
3186 - Brighton
Recruitment postcode(s) [3] 41899 0
4209 - Willow Vale

Funding & Sponsors
Funding source category [1] 315628 0
Self funded/Unfunded
Name [1] 315628 0
Patient is self-funding
Country [1] 315628 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Insitute of Integrative Medicine, 21 Burwood Rd, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 317725 0
None
Name [1] 317725 0
Address [1] 317725 0
Country [1] 317725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314512 0
National Institute of Integrative Medicine Human Research Ethics Committee (NIIM HREC)
Ethics committee address [1] 314512 0
Ethics committee country [1] 314512 0
Australia
Date submitted for ethics approval [1] 314512 0
15/01/2024
Approval date [1] 314512 0
29/02/2024
Ethics approval number [1] 314512 0
0135N_2024

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

Contacts
Principal investigator
Name 131846 0
A/Prof Karin Ried
Address 131846 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 131846 0
Australia
Phone 131846 0
+61399129545
Fax 131846 0
Email 131846 0
[email protected]
Contact person for public queries
Name 131847 0
Karin Ried
Address 131847 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 131847 0
Australia
Phone 131847 0
+61399129545
Fax 131847 0
Email 131847 0
[email protected]
Contact person for scientific queries
Name 131848 0
Karin Ried
Address 131848 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 131848 0
Australia
Phone 131848 0
+61399129545
Fax 131848 0
Email 131848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21964Ethical approval    387197-(Uploaded-01-03-2024-16-49-18)-Study-related document.pdf



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.