Integrating Loco-Regional Hyperthermia Into the Current Oncology Practice: SWOT and TOWS Analyses.
Niloy R Datta, H Petra Kok, Hans Crezee...
https://pubmed.ncbi.nlm.nih.gov/32596144/Actively Recruiting
Led by Mahatma Gandhi Institute of Medical Sciences · Updated on 2024-09-19
500
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the safety and effectiveness of hyperthermia combined with radiotherapy andor chemotherapy in patients with locally advanced cancers such as head and neck, cervix, breast, oesophagus, and anorectal cancers. This registry trial is conducted at MGIMS in a rural setting with limited resources, focusing on cost-effective cancer treatments that do not add significant side effects. Hyperthermia is being studied as a treatment that raises tumor temperature to enhance the effects of radiotherapy and chemotherapy while being affordable for low-income settings. Hyperthermia treatment is delivered using a repurposed shortwave diathermy machine operating at 27.1 MHz. Patients receive hyperthermia once or twice weekly for 60 to 90 minutes, depending on their tolerance. They may be treated with radiotherapy and hyperthermia, concurrent chemoradiotherapy and hyperthermia, or neoadjuvant chemotherapy and hyperthermia followed by surgery or radiotherapy. Tumor responses and treatment side effects are assessed using standard clinical criteria during and after treatment. Participants undergo evaluations of tumor control, disease-free survival, and overall survival at scheduled time points, including 3 months and about 1 year after treatment. Safety is monitored by recording acute and late treatment-related side effects. Researchers also assess the feasibility of using the modified diathermy device for delivering hyperthermia. The study involves regular follow-up visits and clinical assessments to collect uniform data on outcomes and safety over the study period.
CONDITIONS
Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers
N
Niloy R Datta, MD, DNB, CCST
P
Pratik D Aher, MD
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Mahatma Gandhi Institute of Medical Sciences
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of standard treatment protocols depending on tumor type and stage
Participants receive hyperthermia treatment once or twice a week using a shortwave diathermy unit in combination with radiotherapy and/or chemotherapy according to standard departmental protocols.
Weekly visits for hyperthermia treatments
Duration - Up to 1 year after treatment completion
Participants are monitored for tumor response, acute and late treatment-related morbidity, disease-free survival, and overall survival after completing their primary treatment.
Visits for assessments at 3 months and periodic follow-ups up to 1 year
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/35053479/Mahatma Gandhi Institute of Medical Sciences
Lead Sponsor