None listed
Conditions
Brief summary
This study aims to determine whether injection of a corticosteroid (triamcinolone acetonide) directly into squamous cell carcinoma (SCC) lesions of elderly patients (older than 70) is safe and whether this drug has any effect on the size of the lesions. Who is it for? You may be eligible for this study if you are aged 70 or older, you have at least one lesion on either of your legs clinically consistent with low-grade SCC, and you have been deemed to be at high risk of surgical complications because of pre-existing lower limbs conditions (such as diabetes mellitus, chronic venous disease affecting the lower limbs, previous lower leg cellulitis, previous poor wound healing at the legs, lower limb oedema). Study details All participants who choose to enrol in this study will undergo a biopsy of one of their SCC lesions to determine the severity of the lesion and whether they are eligible to enrol in this study. Two weeks after this biopsy, eligible participants will be randomly allocated by chance (similar to flipping a coin) to have their SCC lesion injected with either the corticosteroid drug or a placebo (sterile injection solution). A maximum of one injection will be made over a 5 week period. Prior to this injection and after the last review at 5 weeks, all participants will be asked to complete two questionnaires about their lower limb function and quality of life. These questionnaires are anticipated to take 20 minutes. No further study visits will be required after the 5 weeks. It is hoped this research will demonstrate that corticosteroid injection into SCC lesions is safe and able to reduce the size of the lesions, which may then be used to improve health outcomes for future patients with SCC.
Interventions
Intralesional triamcinolone acetonide (TAC; 40mg/mL) for cutaneous squamous cell carcinomas (cSCCs) affecting the lower limb in elderly patients. TAC will be administered in clinic as a single injection by dermatologists and melanoma surgeons to a maximum volume of 1mL depending on tumour size.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 70 years or older 2. Lower limbs clinically deemed to be high risk for wound healing (including but not limited to diabetes mellitus; chronic venous disease changes affecting the lower limb; lipodermatosclerosis; history of lower limb cellulitis; history of poor wound healing on lower legs; lower limb oedema) 3. Potential participants must have at least one lesion on the legs clinically consistent with low-grade SCC. Biopsy would be taken (3mm punch) as per standard clinical practice. If confirmed to be SCC, the tumour(s) must be histologically proven primary low-grade cutaneous SCC of the lower limb 4. Low-grade tumours must have zero high-risk factors as per Brigham and Women’s Hospital Tumour Staging system for cSCC. These risk factors include: - Diameter greater than or equal to 2cm - Poorly-differentiated histology - Perineural invasion greater than or equal to 0.1mm - Tumour invasion beyond fat 5. Patient agreeable to delay in surgical excision. It should be noted that the 5 week duration of the trial falls within usual time to excision of well-differentiated cSCC on the lower limbs in the clinics which is 1-2 months. 6. Willingness and ability to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. Histologically proven cSCC that are moderately or poorly differentiated 2. Unable to follow up for the duration of the study due to frailty, geographical or social reasons 3. Known contraindication to injection of triamcinolone acetonide (such as hypersensitivity to ingredients). 4. Patient prefers surgical excision 5. Patient undertaking other treatment for the lesion or lesions (such as field treatments, radiotherapy, photodynamic therapy) 6. Immune suppression (including transplant recipients, chronic haematological malignancies, immune-suppressive medications for autoimmune disorders)
Outcome results
None listed