ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors

NCT07793214 | Recruiting

• 1 other identifier: HEAIS-009
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors; Advanced Solid Tumors Cancer

Keywords

Whole-Body Infrared Hyperthermia; ET-SPACE; Metabolic Reprogramming; Immune Modulation; Palliative Care; Quality of Life; Cancer Pain; Nutritional Status

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.

• 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.

  Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.

• 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.

  Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.

• 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.

  Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.

• Change From Baseline in Eastern Cooperative Oncology Group Performance Status at Week 4

  Eastern Cooperative Oncology Group performance status ranges from 0 to 5, with higher grades indicating poorer functional status. Improvement is defined as a decrease of one or more grades, deterioration as an increase of one or more grades, and stability as no change.

  Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.

• Mean Change From Baseline in Systemic Immune-Inflammation Index

  The Systemic Immune-Inflammation Index will be calculated as the peripheral platelet count multiplied by the neutrophil count and divided by the lymphocyte count. The outcome will evaluate acute and short-term changes in systemic immune-inflammatory status.

  Baseline within 7 days before the first hyperthermia session, 24 to 72 hours after the first session, and Week 4, plus or minus 7 days.

• Mean Change From Baseline in Peripheral Blood CD4 to CD8 T-Cell Ratio

  The ratio of CD4-positive T lymphocytes to CD8-positive T lymphocytes will be measured by flow cytometry when available. The outcome will evaluate changes in peripheral cellular immune status.

  Baseline within 7 days before the first hyperthermia session, 24 to 72 hours after the first session, and Week 4, plus or minus 7 days.

Secondary Outcomes (7)

• Change From Baseline in Patient-Generated Subjective Global Assessment Nutritional Category

  Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.

• Mean Change From Baseline in Daily Oral Morphine Equivalent Dose at Week 4

  Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.

• Number of Participants With Whole-Body Infrared Hyperthermia-Related Adverse Events

  From the first hyperthermia session through 30 days after the final hyperthermia session, assessed for up to 16 weeks.

• Response Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1

  From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.

• Disease Control Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1

  From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.

Study Arms (1)

ET-SPACE Whole-Body Infrared Hyperthermia Cohort

Patients with advanced solid tumors who received ET-SPACE whole-body infrared hyperthermia as part of routine clinical care between January 1, 2022, and December 31, 2028. Participants will be identified retrospectively from existing medical records or followed prospectively. Clinical, laboratory, treatment, safety, symptom, quality-of-life, nutritional, immune, inflammatory, and metabolism-related data will be collected before and after hyperthermia, when available. Hyperthermia exposure and all concomitant anticancer or supportive treatments are determined by the treating physicians and are not assigned by the study protocol.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Hospital: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310030, China

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pengyuan Liu, Dr.

CONTACT

+86-18368846455; oncologyliupengyuan@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Oncology

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CN (1)