Normal saline administered intraperitoneally at defined times

Local anesthetic (ropivacaine) administered intraperitoneally at defined time intervals, similar to placebo arm

Ovarian Cancer

Experimental drug will be administered intraperitoneally

Ropivacaine

Placebo will be administered intraperitoneally

Saline Solution

Karolinska Hospital, Solna

Intra-Peritoneal Local Anaesthetics in Ovarian Cancer

A Randomised Double Blind, Multicentre Trial to Assess Time-interval Between Cytoreductive Surgery and Adjuvant Chemotherapy When Local Anaesthetic is Administered Intraperitoneally, Perioperatively

Days after surgery that the first dose of chemotherapeutic agent is given intravenously.

All complications associated with surgery and anaesthesia will be recorded

Number of patients alive at given time frame will be recorded

All study data will be retained at site of patient recruitment. Primary investigator and statistician will only have access to coded patient identity

Anil Gupta

Associate Professor

Karolinska Institutet

Karolinska University Hospital

Randomised, double blind, prospective, multicenter

Study drugs are blinded and administered perioperatively. Fully blinded for all (participants, assessors etc)

Hypothermia, Accidental

Forced-air warming device will be connected to the trouser legs of the thermal suit.

Thermal suit

The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.

Conventional hospital clothes

TAYS Hatanpää

Thermal Suit With Forced-air Warming in Breast Cancer Surgery

Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation

Core temperature after arriving to the post-anaesthesia care unit

Tampere University Hospital

To assess safety and tolerability of scalp and limb hypothermia, as well as to determine the optimal temperature and pressure to be used. Establishing the occurrence or lack of core hypothermia will be studied.

Once the optimal temperature and pressure of scalp and limb hypothermia is established in healthy patients, a group of cancer patients will undergo concomitant scalp and limb hypothermia over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Part 1: Establishing optimal temperature for hypothermia therapy. Healthy subjects will undergo 3 hours of cryocompression various temperature levels.
Part 2: Establishing optimal pressure for hypothermia therapy. Each subject will undergo cryocompression (fixed at the lowest tolerated temperature established in Section 1) over 3 hours. The pressure ranges to be tested are either low, medium, or high.
Part 3: Establishing safety and tolerability of scalp hypothermia. Scalp hypothermia will be administered over 3 hours using the cooling cap attached to the cooling device.
Part 4: Establishing safety and tolerability of concomitant therapy. Subjects will undergo simultaneous scalp hypothermia and four-limb cryocompression at the temperature and pressure established in Sections 1 and 2. The concomitant therapy will be administered over 3 hours.

Concomitant limb cryocompression and scalp cooling

The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles.
Paclitaxel will be administered as a one-hour infusion. Concomitant scalp cooling and limb cryocompression sessions comprised of a pre-cooling period (one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, hypothermia will be administered for no longer than four hours.
Cryocompression will be administered on patients based on the lowest tolerated temperature and optimal pressure as determined in healthy subjects.

National University Hospital Singapore

Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia

National University Hospital, Singapore

This study will consist of two parts:
A) Healthy subjects: To assess safety and tolerability of scalp and limb hypothermia, as well as to determine the optimal temperature and pressure to be used. Establishing the occurrence or lack of core hypothermia will be studied.
B) Cancer patients: Once the optimal temperature and pressure of scalp and limb hypothermia is established in healthy patients, a group of cancer patients will undergo concomitant scalp and limb hypothermia over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.

hypothermia/ailse chíche

Intra-Peritoneal Local Anaesthetics in Ovarian Cancer

Thermal Suit With Forced-air Warming in Breast Cancer Surgery

Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia

An bunachar luibheanna míochaine is iomláine le tacaíocht ón eolaíocht