Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical research study is to learn about how well levorphanol can control cancer pain.

This is an investigational study. Levorphanol is FDA approved and commercially available for the treatment of pain. It is investigational to learn about how helpful it is in treating pain in cancer patients.

Up to 86 participants will be enrolled in this study. All will take part at MD Anderson.


Clinical Trial Description

Objectives:

Primary Objective:

1. To determine the proportion of successful opioid rotation (OR) from MEDD to levorphanol on day 10 +/- 1 after rotation.

Secondary Objectives:

1. To determine the median opioid rotation ratio (ORR) in patients undergoing successful opioid rotations from morphine equivalent daily dose (MEDD) to Levorphanol in the Supportive Care Center (SCC). ORR will be calculated on day 10 +/- 1 as levorphanol mg (day 10 +/- 1) / MEDD mg (day 0) for each patient.

2. To determine the effect of levorphanol on cancer pain (as measured by change in Edmonton Symptom Assessment System's [ESAS] pain item from baseline) in cancer outpatients undergoing opioid rotation to Levorphanol on day 10 +/- 1 of treatment.

3. To determine the association between the opioid rotation ratio from MEDD to levorphanol and baseline MEDD prior to opioid rotation.

4. Measure levorphanol related side effects using the Opioid Side Effect Scale at day 10 +/- 1 of starting Levorphanol.

5. Determine what percentage of patients rotated to levorphanol achieve their personalized pain goal.

6. Determine the predictors of successful opioid rotation from other opioids to levorphanol ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03579446
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Akhila Reddy
Phone 713-745-2668
Email asreddy@mdanderson.org
Status Recruiting
Phase Early Phase 1
Start date November 29, 2018
Completion date January 16, 2019

See also
  Status Clinical Trial Phase
Completed NCT01441141 - Genetics and Pain Severity in Sickle Cell Disease
Recruiting NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Recruiting 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
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Enrolling by invitation NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03459872 - Acupuncture Outcomes Based Rehabilitation N/A
Recruiting NCT03256487 - Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department Phase 2
Recruiting NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Completed NCT03690609 - CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers N/A
Completed NCT02533908 - Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children Phase 3
Not yet recruiting NCT03260972 - Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control Phase 3
Not yet recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
Not yet recruiting NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Recruiting NCT02943772 - Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake? N/A
Recruiting NCT02829736 - ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively N/A