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

Trial ID: NCT04469075

Interventional - Phase 2 - Active, not recruiting

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.

Conditions

• Glioblastoma
• Recurrent Glioblastoma
• Skin Toxicity

Interventions

• Clindamycin Phosphate
• Triamcinolone Acetonide

Eligibility

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

Sponsor

Memorial Sloan Kettering Cancer Center

Source: ClinicalTrials.gov

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