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Trial record 7 of 13 for:    dry mouth | Recruiting Studies | NIH

Levorphanol as A Second Line Opioid in Reducing Pain in Participants With Cancer

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ClinicalTrials.gov Identifier: NCT03579446
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasm Metastatic Malignant Neoplasm Pain Drug: Hydrocodone Drug: Hydromorphone Hydrochloride Drug: Levorphanol Drug: Morphine Sulfate Drug: Oxycodone Drug: Oxymorphone Hydrochloride Other: Questionnaire Administration Early Phase 1

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : January 16, 2019
Estimated Study Completion Date : January 16, 2019

Arm Intervention/treatment
Experimental: Supportive care (levorphanol, opioid regimen)
Participants receive levorphanol PO every 8 or 12 hours for 30 days. Participants may receive opioid regimen including hydrocodone, morphine sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain.
Drug: Hydrocodone
Given PO

Drug: Hydromorphone Hydrochloride
Given PO
Other Names:
  • Dilaudid
  • Dilaudid HP
  • Dimorphone
  • Exalgo
  • Hydrostat
  • Hymorphan
  • Laudicon
  • Novolauden

Drug: Levorphanol
Given PO

Drug: Morphine Sulfate
Given PO
Other Names:
  • Avinza
  • Infumorph
  • Kadian
  • MS Contin
  • MSir
  • Oramorph
  • Oramorph SR
  • Roxanol
  • Statex SR

Drug: Oxycodone
Given PO
Other Name: Oxycodone SR

Drug: Oxymorphone Hydrochloride
Given PO
Other Names:
  • Numorphan
  • Opana
  • Opana ER

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol [ Time Frame: Day 10 ]
    Bayesian methodology developed by Peter Thall will be used to monitor the study. This method decides whether levorphanol is promising relative to the standard medicine. Will estimate the proportion of successful opioid rotation along with a 95% confidence interval. Association between successful opioid rotation and demographic/clinical characteristics will be examined by Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will be employed to assess the effect of demographic/clinical characteristics on the presence of successful opioid rotation.


Secondary Outcome Measures :
  1. Opioid rotation ratio (ORR) [ Time Frame: Up to 30 days ]
    Will be calculated by levorphanol mg (day 10 +/- 1) over MEDD (day 0). ORR will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on ORR between/among patients' characteristics groups.

  2. Change of Exercise Self-Efficacy Scale (ESES) pain score [ Time Frame: Baseline to day 10 ]
    Pain score change will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on pain score change between/among patients' characteristics groups. Since ESAS pain score will be measured daily from day 0 to day 10 +/- 1 and on day 30 +/- 3, mixed model will be applied to examine the differential changes over time for ESAS pain score, adjusting for other covariates of interest. ORR and baseline MEDD will be presented by scatter plots. Correlation will be assessed between levorphanol dose on day 10 +/- 1, ORR and baseline MEDD suing Pearson or Spearman correlation coefficient when appropriate. Linear regression models will be applied to estimate the linear association between levorphanol dose on day 10 +/- 1, ORR and baseline MEDD.

  3. Incidence of levorphanol related side effects [ Time Frame: Up to day 30 ]
    Will be rated using the Opioid Side Effect Scale on xerostomia, nauseas, constipation, drowsiness and confusion daily from day 0 to day 10 +/-1 and on day 30 +/- 3.

  4. Personalized pain goal (PPG) [ Time Frame: Up to day 30 ]
    PPG will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Mixed model will be applied to examine the differential changes over time for opioid side effect scale, adjusting for other covariates of interest. The goal is not achieved if the PPG is lower than the ESAS pain score. Frequency and proportion of achieved goal will be summarized.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients seen in the SCC with a diagnosis of cancer with or without evidence of metastatic disease
  2. Diagnosis of cancer related pain currently treated with first line strong oral opioid analgesics such as morphine, oxycodone, oxymorphone, hydromorphone or hydrocodone.
  3. Age 18 or older
  4. Able to complete study assessments
  5. Individual is willing to sign written informed consent
  6. Patients who are classified as being opioid tolerant by receiving a baseline MEDD of >/= 60 mg
  7. Patients who are local and able to follow-up in the SCC within 30 days if necessary
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 2.
  9. Able to swallow oral medication

Exclusion Criteria:

  1. Cognitive impairment with a Memorial Delirium Assessment Scale (MDAS) score of 7 or higher or diagnosed with neurocognitive impairment by the treating SCC physician.
  2. Renal insufficiency defined as estimated Glomerular filtration rate of <60 or hepatic insufficiency defined as transaminitis or hyperbilirubinemia of > 1.5 times the highest normal value.
  3. Non-English speaking participants as not all assessments are validated in other languages.
  4. Presence of pain primarily due to chemotherapy induced peripheral neuropathy
  5. Non-malignant pain
  6. Patients with history of alcohol or substance abuse by using Cut-down, Annoyed, Guilty, Eye-opener adapted to include Drug use questionnaire (CAGE-AID) score of 2 or higher
  7. Patients receiving methadone or transdermal fentanyl due to reasons such as long and variable half-life and transdermal rather than oral route for delivery of opioids.
  8. Patients receiving scheduled benzodiazepines due to the risk of excessive sedation
  9. Unable or unwilling to sign consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579446


Contacts
Contact: Akhila Reddy 713-745-2668 asreddy@mdanderson.org

Locations
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Akhila S. Reddy    713-745-2668    asreddy@mdanderson.org   
Principal Investigator: Akhila S. Reddy         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Akhila Reddy M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03579446     History of Changes
Other Study ID Numbers: 2017-0925
NCI-2018-01139 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0925 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Second Primary
Analgesics, Opioid
Morphine
Oxycodone
Hydromorphone
Hydrocodone
Oxymorphone
Levorphanol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Adjuvants, Anesthesia