Clinical trial · Interventional
Intra Peritoneal Chemo Hyperthermia (IPCH) : Cellular and Metabolic Consequences
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intra Peritoneal Chemo Hyperthermia (IPCH) is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program demonstrated a significant improvement of the late stages (i.e. carcinomatosis) of the disease. From a clinical point of view, within the first 24 hours after IPCH, patients undergo a systemic inflammatory response syndrome, and therefore require to be monitored in an intensive care unit. From a metabolic perspective, preliminary data have been shown a significant "anaerobic style" disturbance of energetic metabolism, suggesting a deep cellular energetic deficit throughout IPCH process. Putative contradictory effects of IPCH, like the increase of chemotherapy-related cellular toxicity due to heat and on the other hand the initiation of a stress protein response (heat shock response) which helps to reduce the cell injuries, leads to conduct a research project on the underlying mechanisms: consequences, in terms of patient's care and follow-up, are of high relevance. The primary goal is a multimodal assessment of the IPCH-related cell modifications: signaling pathways, apoptosis and antitumoral immune response. The assessment criteria include Heat shock protein expression (blood/cell ratio) compared to baseline values, apoptosis and immune response before/after IPCH. The scheduled sample size is 30 patients having an IPCH and 30 patients contraindicated per surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis From Colorectal or Ovarian Origin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery with IPCH | Procedure | — | UNRESOLVED |
| Without surgery and without IPCH | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery with IPCH
- description
- Patients having an IPCH (Intra Peritoneal Chemo Hyperthermia) during the surgery time
- interventionNames
- Procedure: Surgery with IPCH
- type
- SHAM_COMPARATOR
- label
- patients without IPCH
- description
- Patients recused for the surgery due to intraoperative contraindication
- interventionNames
- Procedure: Without surgery and without IPCH
Primary outcomes (1)
- measure
- heat shock protein expression (blood/cell ratio)compared to baseline values
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patient * eligible for IPCH * with a social security number * having a signed an informed consent Exclusion Criteria: * study refusal * parturiants * psychiatric disorders
References
Publications (0)
Data not yet available