Using topical tretinoin to prevent skin issues from cancer treatment
A Phase II, Randomized, Double-Blind, Split-Face of Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors
This study is testing if a cream called tretinoin can help reduce skin rashes for patients with metastatic colorectal cancer who are receiving certain cancer treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | panitumumab, cetuximab, chemotherapy, radiation |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06358677 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if topical tretinoin can alleviate acneiform rashes in patients with metastatic colorectal cancer undergoing treatment with anti-EGFR agents like panitumumab or cetuximab. Participants will apply tretinoin on one side of their face while a placebo will be applied to the other side, allowing researchers to compare the effects. The study focuses on patients who have confirmed metastatic disease and are eligible for standard-of-care treatments. By assessing the efficacy of tretinoin, the trial seeks to improve the quality of life for patients experiencing skin toxicity from their cancer therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic colorectal cancer who are eligible for treatment with panitumumab or cetuximab.
Not a fit: Patients who are not receiving anti-EGFR therapies or those with non-metastatic colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce skin toxicity and improve the quality of life for patients undergoing anti-EGFR therapy.
How similar studies have performed: While the specific use of topical tretinoin for this purpose may be novel, similar studies have shown promise in managing skin toxicity from cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Participant aged ≥ 18 years
* Histologically confirmed solid tumor.
* Radiologically confirmed locally advanced or metastatic disease.
* Eligible for and willing to receive treatment with panitumumab or cetuximab as standard-of-care.
* ECOG Performance Status ≤ 2.
* Adequate organ function as defined as:
--Hepatic:
* Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
* Negative pregnancy test for participants who have not undergone surgical sterilization or shown evidence of post-menopausal status. The following age-specific requirements apply:
--\< 50 years of age:
* Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
* Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
* Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
--≥ 50 years of age:
* Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
* Had radiation-induced menopause with last menses \>1 year ago; or
* Had chemotherapy-induced menopause with last menses \>1 year ago; or
* Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
* Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.2.
* Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events less than or equal to grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by an investigator with appropriate documentation.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
* Treatment with an anti-EGFR agent within 90 days of registration.
* Pre-existing facial rash that per the treating investigator would preclude the ability to assess response to topical tretinoin.
* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
* Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Systemic active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
--Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
* Participants taking prohibited medications as described in Section 6.8.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Nevala-Plagemann, MD — Huntsman Cancer Institute
- Study coordinator: Susan Sharry
- Email: susan.sharry@hci.utah.edu
- Phone: 801-585-3453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.