ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorZhejiang Hospital
About this trial
This ambispective observational cohort study will evaluate biological changes, palliative outcomes, and safety associated with ET-SPACE whole-body infrared hyperthermia in patients with advanced solid tumors. This noninvasive treatment uses infrared energy to raise body temperature in a controlled manner. Patients who received the treatment between January 1, 2022, and December 31, 2028, will be included. Earlier cases will be assessed retrospectively using medical records, while subsequently enrolled patients will be followed prospectively. Hyperthermia and all anticancer or supportive treatments will be provided according to routine clinical practice and will not be assigned by the study.
The study will collect patient and tumor characteristics, laboratory findings, anticancer and supportive treatments, hyperthermia parameters, adverse events, and follow-up outcomes. It will assess changes in metabolism-related indicators, immune and inflammatory function, nutritional status, quality of life, cancer-related pain, functional status, symptom burden, and tumor-specific palliative scores. The study will also explore factors associated with more favorable outcomes and clarify the potential supportive and palliative role of whole-body infrared hyperthermia in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will comprise consecutive adults with unresectable locally advanced, recurrent, or metastatic solid tumors who initiated at least one session of ET-SPACE whole-body infrared hyperthermia at Zhejiang Hospital between January 1, 2022, and December 31, 2028. Retrospective participants will be identified from electronic medical records and hyperthermia treatment records, while prospective participants will be consecutively enrolled and followed using the same eligibility criteria. No restrictions will be imposed based on sex, primary tumor type, metastatic site, treatment line, previous or concomitant anticancer therapy, performance status, comorbidities, or number of hyperthermia sessions. Participants with missing individual laboratory tests, questionnaires, imaging assessments, or follow-up variables will remain eligible, provided that the diagnosis and hyperthermia exposure can be confirmed.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: ET-SPACE Whole-Body Infrared Hyperthermia Cohort
Trial outcomes
Primary outcomes
1
Mean Change From Baseline in Prognostic Nutritional Index at Week 4
The Prognostic Nutritional Index will be calculated as serum albumin in grams per liter plus five multiplied by the absolute lymphocyte count in 10\^9 cells per liter. Higher values generally indicate better nutritional and immunological status.
Time frame
Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.2
Mean Change From Baseline in Cancer Pain Intensity at Week 4
Cancer-related pain will be assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The outcome will be calculated as the Week 4 score minus the baseline score.
Time frame
Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.3
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Week 12
The EORTC QLQ-C30 global health status scale ranges from 0 to 100, with higher scores indicating better overall health and quality of life. This outcome evaluates the durability of quality-of-life changes.
Time frame
Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.4
Mean Change From Baseline in Edmonton Symptom Assessment System-Revised Total Score at Week 4
The Edmonton Symptom Assessment System-Revised evaluates nine common symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden.
Time frame
Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.Secondary outcomes
1
Change From Baseline in Patient-Generated Subjective Global Assessment Nutritional Category
Nutritional status will be classified using the Patient-Generated Subjective Global Assessment as Category A, well nourished; Category B, moderately or suspected of being malnourished; or Category C, severely malnourished. Changes between categories will be reported.
Time frame
Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.2
Mean Change From Baseline in Daily Oral Morphine Equivalent Dose at Week 4
Daily opioid consumption will be converted to oral morphine equivalent dose in milligrams per day using standardized conversion factors. The outcome will evaluate changes in analgesic requirements.
Time frame
Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.3
Number of Participants With Whole-Body Infrared Hyperthermia-Related Adverse Events
Adverse events considered possibly, probably, or definitely related to whole-body infrared hyperthermia will be recorded and graded according to the Common Terminology Criteria for Adverse Events version 5.0. The number and percentage of participants experiencing any adverse event and Grade 3 or higher adverse events will be reported.
Time frame
From the first hyperthermia session through 30 days after the final hyperthermia session, assessed for up to 16 weeks.4
Response Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1
Objective response rate is defined as the percentage of evaluable participants whose best overall response is complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1. Tumor response may reflect all concomitant anticancer treatments received during the observation period.
Time frame
From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.Sponsors and contacts
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Source ClinicalTrials.gov