Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062938) titled 'Immediate changes in sleepiness and sustained attention following intravenous chemotherapy: a single-center prospective pilot study' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Nagoya University

Condition: Condition - Pancreatic cancer and gynecologic cancers (ovarian, endometrial, and cervical cancers) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objectives of this study are twofold: (1) to investigate, using a simple screening, factors that may affect driving performance in patients undergoing chemotherapy, including cognitive function and symptoms of anxiety and depression; and (2) to assess changes in sleepiness and sustained attention before and after chemotherapy administration using a tablet device. The treatment regimens evaluated in this study are gemcitabine plus nab-paclitaxel (GnP) and paclitaxel plus carboplatin (TC). Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Patients will undergo assessments including the KSS, PVT, trail making test part B (TMT-B), Hospital Anxiety and Depression Scale (HADS), and a questionnaire assessing sleep status. The KSS and PVT will be assessed before and 15 and 60 minutes after chemotherapy administration. The TMT-B, HADS, and sleep status questionnaire will be assessed before chemotherapy administration. The measurement conditions will be standardized as much as possible. Specifically, patients and the nurses in charge will be instructed in advance to avoid sleeping during chemotherapy administration, excessive physical activity, and caffeine intake. During the measurements, they will also be instructed to avoid conversations with others, use of mobile phones or other devices, and other unnecessary external stimuli. If any of these factors cannot be avoided, they will be recorded.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients who undergo GnP therapy or TC with or without other therapy between the date of study approval and March 31, 2030. Key exclusion criteria - (1) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of >2. (2) The presence of apparent higher-order cognitive impairment due to brain metastases or a history of neurological disease or other conditions. (3) Grade >2 peripheral neuropathy. (4) Use of sleeping medication, including as-needed medication, or other medications with drowsiness as a side effect from 2 days before the study assessment through the day of chemotherapy administration. (5) Inability to provide written informed consent to participate in this study. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072011

Disclaimer: Curated by HT Syndication.