Clinical trial · Interventional
Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab
A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress
- 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)
This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab
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 |
|---|---|---|---|
| Dermatologic Complications | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| management of therapy complications | Procedure | — | UNRESOLVED |
| menadione topical lotion | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (lotion)
- description
- Patients apply menadione topical lotion BID for 28 days.
- interventionNames
- Drug: menadione topical lotion
- Other: questionnaire administration
- Procedure: management of therapy complications
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients apply topical placebo lotion BID for 28 days.
- interventionNames
- Other: placebo
- Other: questionnaire administration
Primary outcomes (1)
- measure
- Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older. * Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity. * Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face. * Ability to complete questionnaire(s) by themselves or with assistance. * Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only. * Willing to have photographs taken to assess rash. Exclusion Criteria: * Any active facial and/or chest rash, including adult acne, at the time of randomization. * Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest. * Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks. * Any type of ongoing therapy for rash. * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects * Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.
References
Publications (0)
Data not yet available