Clinical trial · Interventional
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
NCT04469075CI-TRIAL-00121130active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Skin Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clindamycin Phosphate | Drug | — | UNRESOLVED |
| Triamcinolone Acetonide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- topical clindamycin and triamcinolone
- description
- Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval
- interventionNames
- Drug: Clindamycin Phosphate
- Drug: Triamcinolone Acetonide
Primary outcomes (1)
- measure
- Number of patients without grade 2 or higher skin toxicity
- timeFrame
- up to 120 days
- description
- device-related skin adverse events by investigator assessment.
Secondary outcomes (1)
- measure
- skin-related quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.