Clinical trial · Interventional
Sleep and Endometrial Cancer
Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain
NCT00936598CI-TRIAL-00014341terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator-initiated termination of approval due to problems with recruitment.
Summary
Brief summary (as posted)
This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sugar pill | Drug | — | UNRESOLVED |
| zolpidem | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- zolpidem
- description
- Participants randomized to the zolpidem (intervention) group will receive the FDA approved dose of zolpidem, (10 mg for women \<65; 5 mg for women \> or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. During their presurgery visit (visit 1), participants will be provided with their capsule and instructed to take it by mouth immediately before bedtime the night before surgery.
- interventionNames
- Drug: zolpidem
- type
- PLACEBO_COMPARATOR
- label
- sugar pill
- description
- Participants randomized to the sugar pill (control) group will receive placebo. For the purposes of this double-blind trial, placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. During their presurgery visit (visit 1), participants will be provided with their capsule and instructed to take it by mouth immediately before bedtime the night before surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * be women at least 18 years old * have clinical indications of primary endometrioid adenocarcinoma of the endometrium * be scheduled for staging surgery by laparotomy under standardized protocols * have the ability to communicate in English sufficient for completion of study materials * have no neuromuscular/ movement disorders (for actigraphy purposes) * have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care) * have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids) Exclusion Criteria: * have a history of previous or concomitant cancer * have an estimated life expectancy of \< 6 months * will be admitted to the hospital prior to the day of surgery * are unable to complete study measures * are unable to provide meaningful informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.