Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058454) titled 'Preventive Effect of Intraoral Cooling on Taste Dysfunction in Early Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Pilot Study' on July 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kawasaki Medical School

Condition: Condition - breast cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study is a pilot study aimed at exploring the effect of intraoral cooling as a preventive measure against chemotherapy-induced taste dysfunction in patients with early-stage breast cancer. The objectives are to assess the incidence and severity of taste dysfunction (based on patient-reported outcomes and healthcare provider assessments), as well as the safety and feasibility of intraoral cooling, in order to collect foundational data for a larger-scale study. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Ice chips or ice water Interventions/Control_2 - usual care

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 20 years or older 2. Patients with histologically confirmed primary breast cancer 3. Patients scheduled to receive any of the following as adjuvant therapy for early-stage breast cancer:    -Dose-dense doxorubicin + cyclophosphamide (AC) / epirubicin + cyclophosphamide (EC) with or without docetaxel (DTX) or paclitaxel (PTX)    -Docetaxel + cyclophosphamide (TC)    -Trastuzumab + paclitaxel (HT)    -Trastuzumab + docetaxel (HDTX)    -As neoadjuvant therapy: pembrolizumab (Pembro), PTX, and carboplatin (CBDCA), followed by Pembro + AC or EC 4. Patients without taste dysfunction 5. Patients capable of using electronic devices 6. Patients who can provide written informed consent of their own free will Key exclusion criteria - 1. Determined by the attending physician to be inappropriate for inclusion in the study. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 10 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066434

Disclaimer: Curated by HT Syndication.