ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors (HEAIS-009)
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
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pengyuan Liu, Dr.
- Numéro de téléphone: +86-18368846455
- E-mail: oncologyliupengyuan@outlook.com
Lieux d'étude
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chine, 310030
- Recrutement
- Zhejiang Hospital, Department of Oncology, Hangzhou, China, 310030
-
Contact:
- Pengyuan Liu, Dr.
- Numéro de téléphone: +86-18368846455
- E-mail: oncologyliupengyuan@outlook.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Change From Baseline in Prognostic Nutritional Index at Week 4
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Patient-Generated Subjective Global Assessment Nutritional Category
Délai: Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.
|
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.
|
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
Délai: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
|
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.
|
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
Délai: From the first hyperthermia session through 30 days after the final hyperthermia session, assessed for up to 16 weeks.
|
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.
|
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
Délai: From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.
|
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.
|
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
Délai: From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.
|
Disease control rate is defined as the percentage of evaluable participants whose best overall response is complete response, partial response, or stable disease 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
Délai: From the first hyperthermia session until disease progression or death, assessed for up to 12 months.
|
Progression-free survival is defined as the time from the first whole-body infrared hyperthermia session to the first documented disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 or death from any cause, whichever occurs first.
Participants without an event will be censored at the date of their last evaluable disease assessment.
|
From the first hyperthermia session until disease progression or death, assessed for up to 12 months.
|
|
Overall Survival
Délai: From the first hyperthermia session until death from any cause, assessed for up to 12 months.
|
Overall survival is defined as the time from the first whole-body infrared hyperthermia session to death from any cause.
Participants who remain alive will be censored at the date they were last known to be alive.
|
From the first hyperthermia session until death from any cause, assessed for up to 12 months.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HEAIS-009
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .