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NCT Number: NCT04469075

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glioblastoma Astrocytoma Disease Attributes Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Glioblastoma Skin Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University, Evanston, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clindamycin Phosphate

Drug

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

Triamcinolone Acetonide

Drug

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

Primary outcomes

  1. Number of patients without grade 2 or higher skin toxicity

    Time frame: up to 120 days

    device-related skin adverse events by investigator assessment.

Secondary outcomes

  1. skin-related quality of life

    Time frame: up to 120 days

    using the PRO-CTCAE for rash, ulcer, and pruritus.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2020
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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