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
1 other identifier
interventional
48
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2020
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2020
CompletedFirst Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
August 8, 2025
August 1, 2025
6 years
July 10, 2020
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients without grade 2 or higher skin toxicity
device-related skin adverse events by investigator assessment.
up to 120 days
Secondary Outcomes (1)
skin-related quality of life
up to 120 days
Study Arms (1)
topical clindamycin and triamcinolone
EXPERIMENTALPatients 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
Interventions
phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)
triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Northwestern University
Evanston, Illinois, 60208, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center Suffolk - Hauppauge (All Protocol Activities)
Hauppauge, New York, 11788, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Columbia University
New York, New York, 10032, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alina Markova, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 13, 2020
Study Start
July 9, 2020
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.