Clinical trial NCT06744764: Pulsed Electromagnetic Fields in Preventing Physical Deconditioning in Patients Undergoing Prolonged Hospitalization
Official title: Pulsed Electromagnetic Fields in Preventing Physical Deconditioning in Patients Undergoing Prolonged Hospitalization: A Case Match Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Haematological Cancer
Healthy
Keywords: Magnetic therapy
Cancer management
Muscle atrophy
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to examine if pulsed electromagnetic fields (PEMF) can prevent or decrease physical deconditioning associated with prolonged hospitalisation and immobility of haematology patients. The main question\[s\] it aims to answer \[is/are\]:

* Does haematology patients undergoing prolonged hospitalisation have no or decreased physical deconditioning when exposed to PEMF?
* What are the changes in muscle secretome at baseline and after exposure to PEMF? Researchers will compare haematology patients who receive PEMF against patients who did not receive the treatment to see if there is a change in physical deconditioning. Healthy volunteers will also be recruited and randomized to either exposure to PEMF or no exposure.

Haematology patients will

* Have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline.
* Undergo SPPB test at baseline, 4 weeks and 8 weeks from baseline, and the test comprises of the time up and go test, 4 minute walk test and sit to stand test.
* Either expose to PEMF twice per week for 4 consecutive weeks or no exposure. Healthy volunteers will
* Have their blood taken at baseline, 4 weeks from baseline and 8 weeks from baseline.
* Either expose to PEMF twice per week for 4 consecutive weeks or no exposure.


Eligibility criteria: Inclusion Criteria:

* Haematology patients who are undergoing induction chemotherapy for acute leukemia
* Haematology patients who are undergoing haematopoietic stem cell transplant
* Have ECOG 0-24. Able to walk at baseline to participate in short physical battery test.
* For healthy volunteers, subjects have to be healthy without any major disease states, not on any drugs or requiring long term medical attention.

Exclusion Criteria:

* Patients who do not agree to sign the consent form.
* Pregnant women will be excluded from the study for healthy volunteers

Primary outcomes:
measure: Change in physical deconditioning in haematology patients after 8 sessions of PEMF
timeFrame: Change in SPPB test result 4 and 8 weeks from baseline
measure: Changes in the levels of anti-cancer factors in blood plasma from haematology patients and healthy volunteers
timeFrame: Change in anti-cancer biomarkers levels in blood plasma from PEMF-exposed patients at week 4 and week 8 versus their own baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Kent Ridge
country: Singapore
facility: NUHS Investigational Medicine Unit
city: Kent Ridge
country: Singapore
facility: National University Hospital
Study officials:
References:
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citation: Stephenson MC, Krishna L, Pannir Selvan RM, Tai YK, Kit Wong CJ, Yin JN, Toh SJ, Torta F, Triebl A, Frohlich J, Beyer C, Li JZ, Tan SS, Wong CK, Chinnasamy D, Pakkiri LS, Lee Drum C, Wenk MR, Totman JJ, Franco-Obregon A. Magnetic field therapy enhances muscle mitochondrial bioenergetics and attenuates systemic ceramide levels following ACL reconstruction: Southeast Asian randomized-controlled pilot trial. J Orthop Translat. 2022 Oct 13;35:99-112. doi: 10.1016/j.jot.2022.09.011. eCollection 2022 Jul.
citation: Yap JLY, Tai YK, Frohlich J, Fong CHH, Yin JN, Foo ZL, Ramanan S, Beyer C, Toh SJ, Casarosa M, Bharathy N, Kala MP, Egli M, Taneja R, Lee CN, Franco-Obregon A. Ambient and supplemental magnetic fields promote myogenesis via a TRPC1-mitochondrial axis: evidence of a magnetic mitohormetic mechanism. FASEB J. 2019 Nov;33(11):12853-12872. doi: 10.1096/fj.201900057R. Epub 2019 Sep 13.