Clinical trial · Interventional
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
A Two-Part, Phase II Randomized Trial to Explore Topical Spironolactone to Prevent/Attenuate Rash From Epidermal Growth Factor Receptor Inhibitors (Panitumumab and Cetuximab) in Advanced Cancer Patients
NCT01867294CI-TRIAL-00042672completedPhase 2Results postedClinicalTrials.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)
This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Dermatologic Complication | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxycycline | Drug | — | UNRESOLVED |
| Management of Therapy Complications | Procedure | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Spironolactone | Drug | — | UNRESOLVED |
| Sunscreen | Drug | — | UNRESOLVED |
| Therapeutic Hydrocortisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (Study I)
- description
- Patients apply spironolactone topically to face BID for 4 weeks.
- interventionNames
- Other: Questionnaire Administration
- Drug: Spironolactone
- type
- EXPERIMENTAL
- label
- Arm I (Study II)
- description
- Patients apply spironolactone topically to face and body BID for 4 weeks.
- interventionNames
- Other: Questionnaire Administration
- Drug: Spironolactone
- type
- PLACEBO_COMPARATOR
- label
- Arm II (Study I)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization * Ability to reliably apply topical spironolactone/placebo twice a day to the face * Ability to complete questionnaire(s) by themselves or with assistance * For study 2 only, patients must be willing to avoid sun exposure for one month from registration * Creatinine =\< 1.5 x upper limit of normal (UNL) * For Study 2 only, ability to apply topical creams to the entire face and body Exclusion Criteria: * Prior allergic reaction or severe intolerance to spironolactone * Any rash at the time of randomization * Cutaneous metastases * Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist * Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol) * For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)
References
Publications (0)
Data not yet available
No reference posted for this study.