Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Glutathione.

It had two arms (groups): Arm I (glutathione, carboplatin) (experimental) and Arm II (placebo, paclitaxel) (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

To compare the incidences of grade 2+ and grade 3+ TAXOL/CBDCA induced peripheral neuropathy measured by Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale between GSH and placebo arms.

To compare the time to onset of grade 2+ and grade 3+ TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms, measured by CTCAE neuropathy scale.

To compare the proportion of patients stopping TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.

To assess the toxicity profile of GSH in this situation.

Who Took Part

Enrollment: 195 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to sign informed consent and understand the nature of a placebo-controlled trial. Ability to complete English language questionnaire(s) by themselves or with assistance. Life expectancy \>= 6 months. Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only, per clinician discretion. Willingness to provide blood specimens as required by the protocol.

The full record lists 12 inclusion and 11 exclusion criteria; among the exclusions: any of the following:; pregnant women; nursing women.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2009-12 with completion listed for 2012-08.

It ran at 390 sites in United States (390).

Its stated primary purpose is supportive care.

What Was Measured

It also tracked 8 secondary outcomes, for example Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms, Percentage of Patients Delaying PC Chemotherapy Secondary to PN, Times to Onset of CTCAE Grade 2+ PN and Times to Onset of CTCAE Grade 3+ PN.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glutathione in 195 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glutathione compound page, all human trials.