Trial · NCT06162663
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
NCT06162663, Phase 4, Terminated, Medical University of South Carolina
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors. Trials, record NCT06162663. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06162663
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
- NCT number
- NCT06162663
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 6 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Breast Cancer, Insomnia
- Interventions
- Suvorexant Tablets, Placebo Control
- First posted
- 2023-12-08
- Last updated
- 2026-08-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI) | 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. |
| Secondary | Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale | 4 weeks | 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. |
| Secondary | Quality of Life Evaluated Using the SF-36 | 4 Weeks | 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. |
| Secondary | Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL) | 4 weeks | 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. |
| Secondary | Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI) | 4 weeks | 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. |
| Secondary | Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ) | 4 weeks | 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. |
| Secondary | Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale | 2 weeks | 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. |
| Secondary | Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI) | 2 weeks | 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. |
| Secondary | Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI) | 2 weeks | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06162663
GET https://conductscience.org/api/trials/v1/NCT06162663/registered