Efficacy of scalp cooling to prevent chemotherapy-induced alopecia in children with acute lymphoblastic leukemia: A non-randomized trial.
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PURPOSE: Chemotherapy-induced alopecia (CIA) is a common adverse event in children undergoing chemotherapy. Scalp cooling (SC), although effective in adults in preventing CIA, has not been investigated in children. METHODS: We conducted a prospective, non-randomized trial in children with acute lymphoblastic leukemia (ALL) undergoing induction chemotherapy. Participants were sequentially assigned to either SC or non-cooling (NC) groups. SC was done using a pre-cooled Elasto-Gel® cap during chemotherapy infusion (daunorubicin + vincristine). Primary outcome was successful hair preservation (HP), defined as NCI-CTCAE v5.0 alopecia grade-1 at end of induction (EOI). Secondary outcomes included changes in scalp-ultrasonographic and scanning electron microscopic parameters (SEM) along with trichoscopy and trichogram findings. RESULTS: Twenty-two children with a median age of 72 months (IQR: 60-129) were enrolled. One child in the SC and two in the NC group out of 11 in each, died before EOI. Successful HP was achieved in 9/10 in the SC group versus 2/9 in the NC group (p = 0.005). Amongst the sonographic parameters, there was a significantly lesser decrease in dermal thickness in the SC group (- 0.03 mm vs. - 0.3 mm, p = 0.049). Amongst the SEM parameters, there was a significantly better preservation of shaft-diameter (- 7.9 µm vs. - 21.6 µm, p = 0.005) and cuticular scale-density (- 3.5 scales/100 µm vs. - 12 scales/100 µm, p = 0.0004) in the SC group. Trichoscopic and trichogram findings associated with CIA were more pronounced in the NC group. No subjects reported headaches or dizziness during SC. CONCLUSION: SC was associated with a higher likelihood of successful HP in children with ALL undergoing induction chemotherapy. SC is safe and well-tolerated in children with cancer. Further studies investigating the long-term safety outcomes of SC are needed. TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI/2023/06/054343; registered on 22/06/2023).