249TiP A prospective phase II matched case-control study to evaluate the frozen glove therapy to prevent chemotherapy-induced nail pigmentation in patients with early-stage breast cancer

Anthracyclines, cyclophosphamide, or taxanes are commonly used chemotherapy drugs in early-stage breast cancer patients. Nail pigmentation is their common side effect. Previous studies indicated that cryotherapy reduced chemotherapy-induced nail toxicity and was well-tolerated. However, they mainly focused on onycholysis instead of melanonychia and have not explored the prevention of melanonychia. We aim to evaluate the efficacy of cryotherapy in the prevention of chemotherapy-induced nail pigmentation in breast cancer patients and to provide a reference for the management of melanonychia. It’s a prospective, phase II, single-center, matched case-control study. Primary end point: the incidence of severe nail pigmentation. Secondary end points: the degree of nail pigmentation/onycholysis, the incidence of nail pigmentation/onycholysis, the onset time, the duration, and the recovery of nail pigmentation/onycholysis, other cutaneous toxicity, neurotoxicity, and patient comfort. Evaluation criteria:There is no NCI-CTC standard for melanonychia. Area score based on the area of melanonychia: 0 (no change), 1 (0-1/3 area of nail bed), 2 (1/3-2/3 area), 3 (2/3-3/3 area). Color score: 0 (no change), 1 (light), 2 (grey), 3 (black). The most severe finger is evaluated. Severe nail pigmentation: Area score + Color score≥5. Other toxicity is assessed by the NCI-CTC. Patient comfort: dissatisfied (0), not satisfied (1), satisfied (2), or very satisfied (3). Inclusion Criteria: ①Early-stage breast cancer patients who plan to receive anthracyclines, cyclophosphamide or taxane; ②No previous nail/skin abnormalities; ③No upper limb defects; ④No previous antitumor treatment. Exclusion Criteria: Have any condition that can't cooperate. Interventions: Each patient wears a frozen glove on the left hand (30 minutes before the infusion to 30 minutes after the infusion) and has no protection on the right hand as the control side. Sample size estimation: The incidence of severe nail pigmentation in the right-hand control group and the left-hand group are 0.5 and 0.2. α=0.05. β=0.2. Drop-out rate=10%. 41 patients should be enrolled. NCT04215744 Release date: 02/01/2020. Xu Fei. Has not received any funding.