Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00488072 · ClinicalTrials.gov registry record · Phase 2
Effects of Mirtazapine on Appetite in Advanced Cancer Patients
A Phase 2 study of Insomnia and Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT00488072: Active Phase 2 study of Insomnia and Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00488072 is a Phase 2 study of Insomnia and Advanced Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 98 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488072, a Phase 2 study of Insomnia and Advanced Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days). Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days) Other Objectives: To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days). To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).
Primary Outcome
Primary analysis is a comparison of the difference scores in appetite between baseline and 15 days in the two groups. 2-sample t test used to compare differences between groups or a nonparametric test such as the Wilcoxon test if the data are non-normally distributed. A difference of 2 or more in change scores considered to be clinically meaningful.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mirtazapine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2007-01-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT00488072 still lists
NCT00488072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (42% lower).
The record links to 4 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00488072 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00488072 about?
NCT00488072 is a clinical study titled "Effects of Mirtazapine on Appetite in Advanced Cancer Patients". Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom As...
What is the current status of trial NCT00488072?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2007-01-08. Estimated completion is 2027-12-31.
What conditions does trial NCT00488072 study?
This clinical trial studies the following conditions: Insomnia, Advanced Cancer, Weight Loss, Anorexia.
What interventions are being tested in trial NCT00488072?
The interventions under investigation include: Placebo (DRUG), Mirtazapine (DRUG).
Who is sponsoring clinical trial NCT00488072?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00488072 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00488072's enrollment target sits among peer trials
98 68th of 151 higher than 84 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sleep to Reduce Incident Depression Effectively in Peripartum
RECRUITING · Phase 2
-
Pimavanserin for Insomnia in Veterans With PTSD
RECRUITING · Phase 2
-
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
RECRUITING · Phase 2
-
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
RECRUITING · Phase 2
-
Suvorexant for Treatment of AUD and PTSD
RECRUITING · Phase 2
-
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02926729 · 98 participants · NA
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
- NCT03382977 · 98 participants · Phase 1
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
- NCT04577014 · 98 participants · Phase 1
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
- NCT04817618 · 98 participants · Phase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI