Whole-Body Infrared Heating for Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an ambispective observational cohort study of adults with advanced solid tumors receiving ET-SPACE whole-body infrared hyperthermia as part of routine care. The researchers will collect data from retrospective cases (2022) and prospective cases (through 2028) to observe biological changes, palliative outcomes, and adverse events related to the therapy. Hyperthermia sessions and any cancer-directed or supportive treatments are given per standard clinical practice, not dictated by the study protocol. Outcomes include metabolic and immune/metabolic markers, nutritional status, and treatment-related safety indicators, along with follow-up information. The goal is to characterize how this noninvasive treatment may influence disease biology and patient well-being in a real-world setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Hospital, Department of Oncology, Hangzhou, China, 310030
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Pengyuan Liu, Dr.
• Email: oncologyliupengyuan@outlook.com
• Phone: +86-18368846455

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.