RayGel-An Alternative for Skin Care During External Beam Radiation

What Was Tested

This registered phase 2 trial tested Glutathione.

This study is for the patient with breast cancer.

To take part in this study, external beam radiation therapy needs to be part of the treatment plan.

It had two arms (groups): Group A, RayGel Topical Cream (active comparator) and Arm B Placebo Topical Cream (placebo comparator).

RayGel Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

Placebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

The registry classes the interventions as drug.

More on the Plan

External beam radiation is a standard part of breast conservation treatment.

Skin reaction of varying degrees occurs in everyone under going treatment.

Occasionally, it can be so severe that the treatment schedule must be altered to allow healing.

Previous irradiation of the same breast 3.

Who Took Part

150 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: post mastectomy; previous irradiation of the same breast; younger than 18 years of age.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Glutathione.

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

It started in 2004-10 with completion listed for 2011-05.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 150 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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