Clinical trial · Interventional
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers
- 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)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of acitretin may be an effective way to prevent the recurrence or further development of skin cancer. PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-melanomatous Skin Cancer | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acitretin | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- acitretin
- description
- Patients receive oral acitretin daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies. Patients are followed every 6 months.
- interventionNames
- Drug: acitretin
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Patients receive placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies. Patients are followed every 6 months.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- rate of new primary nonmelanoma skin cancers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Solid organ recipient (kidney, liver, heart, lung, or pancreas) receiving immunosuppressive agents (e.g., prednisone, other corticosteroid, azathioprine, cyclosporine, tacrolimus, mycophenolate mofetil) * At least 6 months since transplant * At least 2 prior (same event or separate events) basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) resected * All visible BCC and SCC resected PATIENT CHARACTERISTICS: Age: * 18 and over Life expectancy: * Greater than 2 years Hematopoietic: * WBC at least 3400/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 3 times ULN * SGOT no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Fertile patients must use two effective forms of birth control for at least 1 month before, during, and at least 3 years after study * No history of oral retinoid intolerance * No significant, uncontrolled hyperlipidemia * No other significant medical condition or threatened allograft rejection state where retinoid use would be contraindicated PRIOR CONCURRENT THERAPY: Other: * At least 1 year since prior retinoids * No concurrent oral vitamin A supplements, topical retinoids, or other potentially irritating skin preparations * No alcohol during and for 2 months after study
References
Publications (1)
- RESULTKadakia KC, Barton DL, Loprinzi CL, Sloan JA, Otley CC, Diekmann BB, Novotny PJ, Alberts SR, Limburg PJ, Pittelkow MR. Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251). Cancer. 2012 Apr 15;118(8):2128-37. doi: 10.1002/cncr.26374. Epub 2011 Aug 31. PMID 21882176