Metabolic Reprogramming, Immune Modulation, and Palliative Outcomes Associated With ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors: An Ambispective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Prognostic Nutritional Index at Week 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Mean Change From Baseline in Prognostic Nutritional Index at Week 4
时间窗: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
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.
Mean Change From Baseline in Cancer Pain Intensity at Week 4
时间窗: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
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.
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Week 12
时间窗: Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.
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.
Mean Change From Baseline in Edmonton Symptom Assessment System-Revised Total Score at Week 4
时间窗: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
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.
Change From Baseline in Eastern Cooperative Oncology Group Performance Status at Week 4
时间窗: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
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.
Mean Change From Baseline in Systemic Immune-Inflammation Index
时间窗: 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.
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.
Mean Change From Baseline in Peripheral Blood CD4 to CD8 T-Cell Ratio
时间窗: 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.
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.
次要结局
- 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.)
- Progression-Free Survival(From the first hyperthermia session until disease progression or death, assessed for up to 12 months.)
- Overall Survival(From the first hyperthermia session until death from any cause, assessed for up to 12 months.)
研究者
Pengyuan Liu
Principal Investigator, Department of Oncology
Zhejiang Hospital