Trial intelligence / Profile preview

Glutathione for Prevention of Paclitaxel/Carboplatin Induced Peripheral Neuropathy

NCT02311907Phase 3

Key facts

Status: Completed
Start: Dec 2009
Primary completion: Aug 2012
Countries: 1
Sponsor: Cancer and Leukemia Group B
Modality: Peptides, Recombinant Proteins and Enzymes, Small Molecules

Drugs: glutathione
Conditions: chemotherapy-induced peripheral neuropathy (CIPN)

Overview

Phase 3, randomised, double-blind trial in chemotherapy-induced peripheral neuropathy (CIPN) comparing Glutathione Arm with Placebo Arm (2 arms). Primary endpoint: Paclitaxel/Carboplatin Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20. Started Dec 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Glutathione Arm
Glutathione + Paclitaxel + Carboplatin
Placebo Arm
Placebo + Paclitaxel + Carboplatin

Who it enrols

Patients with ovarian, fallopian tube, or primary peritoneal cancer scheduled for paclitaxel/carboplatin chemotherapy, with no pre-existing neuropathy > grade 1.

Endpoints

Primary

Paclitaxel/Carboplatin Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20up to 6 cycles

Secondary

Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)Up to 1 year
Change in Patient Reported Quality of Life as Assessed by FACT-OBaseline to 1 year
Paclitaxel Acute Pain Syndrome Incidence and SeverityUp to 1 year
Percentage of Patients Delaying PC Chemotherapy Secondary to PNUp to 1 year
Percentage of Patients Undergoing Dose Reductions Secondary to PCI PNUp to 1 year
Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced Peripheral NeuropathyUp to 1 year
Times to Onset of CTCAE Grade 2+ PNUp to 1 year
Times to Onset of CTCAE Grade 3+ PNUp to 5 years

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