Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04469075

Enrollment

Registered

2020-07-13

Start date

2020-07-09

Completion date

2027-07-01

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma, Recurrent Glioblastoma, Skin Toxicity

Keywords

Clindamycin, Triamcinolone, Skin-Related Side Effects, Recurrent, 19-342

Brief summary

The participants are being treated with Tumor Treating Fields (TTFields) for malignant glioma, and this type of treatment may cause skin-related side effects. This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields.

Interventions

DRUGClindamycin Phosphate

phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)

DRUGTriamcinolone Acetonide

triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This is a phase 2, multicenter, open-label study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥18 years * Diagnosis of newly diagnosed or recurrent GBM with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution * Able to self-administer topical interventions or has available another person who can apply the topical agents * Treatment with TTF should be initiated within 7 days of planned initiation on this trial.

Exclusion criteria

* Known history of allergy to any ingredient of the study agents * Preexisting scalp disorders such as psoriasis or dermatitis that, in the opinion of the investigator, will affect the grading of skin adverse events, confirmed by enrolling institution. * Use of concurrent topical therapy to the scalp for another dermatologic condition * Active, uncontrolled infection requiring systemic or oral antibiotic therapy within 14 days of enrollment * Use of greater than 4 mg dexamethasone a day within 14 days of enrollment * Malignant glioma * Pregnant Women

Design outcomes

Primary

Measure	Time frame	Description
Number of patients without grade 2 or higher skin toxicity	up to 120 days	device-related skin adverse events by investigator assessment.

Secondary

Measure	Time frame	Description
skin-related quality of life	up to 120 days	using the PRO-CTCAE for rash, ulcer, and pruritus.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlina Markova, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026