乳がん生存者のスボレキサント

実験的：睡眠衛生に関する情報を提供する Suvorexant

この群に無作為に割り当てられた参加者には、毎日 10 mg のスボレキサントが投与され、7 日目以降は 20 mg に増量されます。薬剤は経口薬として投与されます。 合計期間は 28 日間です。

薬：スボレキサント錠

スボレキサント、最初は10～20 mgを28日間投与

プラセボコンパレーター：Placebo with information on sleep hygiene

Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.

他の：プラセボ対照

28 日間の一致したプラセボ対照

Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)

The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study.

Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale

Vasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Quality of Life Evaluated Using the SF-36

Health-related quality of life was assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). We have reported the average domain score for the general health domain. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL)

Problems related to living with cancer were assessed using the Cancer Problems of Living (CPIL) Scale. The CPIL consists of a multi-item list of cancer-related problems across practical, emotional, and social domains. Participants rate each problem based on perceived severity, with higher ratings indicating greater problem severity. Each item is scored on a scale of 0-2 with the composite score reported. Score range from 0 to 58. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)

Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ)

Medication adherence was assessed using the Simplified Medication Adherence Questionnaire (SMAQ). The SMAQ is a brief, participant-reported questionnaire composed of six multiple-choice questions evaluating medication-taking behavior. Non-adherence is indicated by any positive response suggesting missed doses or by reporting more than two missed doses during the preceding week. The outcome reported was the number of participants who were adherent based on this evaluation. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale

Vasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)

The Insomnia Severity Index (ISI) score was evaluated at baseline, 2 weeks, and 4 weeks. The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)

Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.