Pain Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may
also decrease weight loss and improve muscle strength in cancer patients.
PURPOSE: This randomized clinical trial is studying celecoxib to see how well it works in
managing pain, weight loss, and weakness in patients with advanced cancer.
OBJECTIVES:
Primary
- Compare the symptom burden and functional status, as measured by the physical
well-being subscale of the Functional Assessment of Cancer Therapy-General (FACT-G), of
patients with advanced cancer treated with celecoxib vs placebo.
Secondary
- Compare pain, as measured by the Brief Pain Inventory, in patients treated with these
drugs.
- Compare the need for opioid analgesics, as measured by the oral morphine equivalent of
analgesics used, in patients treated with these drugs.
- Compare weight loss in patients treated with these drugs.
- Compare quality of life, as measured by the FACT-G, in patients treated with these
drugs.
- Compare the median survival of patients treated with these drugs.
- Determine the toxicity of celecoxib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to ECOG performance status (0 or 1 vs 2 or 3), need for opioid
analgesics within the past 2 weeks (yes vs no), and weight loss as percentage of baseline
body weight (< 5% vs ≥ 5%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues in
the absence of unacceptable toxicity.
Quality of life is assessed at baseline and at 2, 6, and 12 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 296 patients (148 per treatment arm) will be accrued for this
study within 2 years.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
| Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
| Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
| Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
| Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
| Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
| Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
| Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
| Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
| Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
| Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
| Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|