NCT07793214 ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors
| NCT ID | NCT07793214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Hospital |
| Condition | Advanced Solid Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Age 18 years or older at the time of the first whole-body infrared hyperthermia session. Histologically, cytologically, or clinically and radiologically confirmed advanced solid malignancy, including unresectable locally advanced, recurrent, or metastatic disease. Initiated at least one session of ET-SPACE whole-body infrared hyperthermia at Zhejiang Hospital between January 1, 2022, and December 31, 2028, as part of routine clinical care. Participants whose treatment was interrupted or not completed may also be included. Medical records contain sufficient information to confirm the diagnosis of a solid malignancy and exposure to ET-SPACE whole-body infrared hyperthermia. Missing individual laboratory tests, questionnaires, imaging assessments, or follow-up variables will not by itself result in exclusion. For the prospective component, written informed consent is provided by the participant or a legally authorized representative. For the retrospective component, informed consent is waived or obtained in accordance with the approval of the institutional ethics review committee. Participants are eligible regardless of sex, primary tumor type, metastatic site, treatment line, previous or concomitant anticancer therapy, performance status, comorbidities, or number of hyperthermia sessions. Exclusion Criteria: No confirmed malignant solid tumor, including participants treated only for a benign condition or a hematologic malignancy. ET-SPACE whole-body infrared hyperthermia was planned but never initiated, or only local or regional hyperthermia was administered. Available records are insufficient to confirm the participant's identity, diagnosis of a solid malignancy, or initiation of ET-SPACE whole-body infrared hyperthermia. Duplicate records or repeated registrations of the same participant; only one consolidated participant record will be included. For the prospective component, refusal or withdrawal of informed consent, unless continued use of previously collected data is permitted by the participant and the ethics review committee.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07793214 clinical trial?
This trial is open to participants of all sexes, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07793214 currently recruiting?
Yes, NCT07793214 is actively recruiting participants. Contact the research team at oncologyliupengyuan@outlook.com for enrollment information.
Where is the NCT07793214 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07793214 clinical trial?
NCT07793214 is sponsored by Zhejiang Hospital. The trial plans to enroll 500 participants.