Lazanda in Cancer Patients Receiving Palliative Radiation
Condition: Bone Metastases
MeSH terms: Neoplasm Metastasis
Intervention: Lazanda
Intervention description: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Advanced cancer patients often require palliative (pain relieving) radiotherapy to treat
      cancer-related symptoms. The delivery of radiation requires patients to lie still on a hard
      flat surface, which can result in significant acute (intense) pain and/or breakthrough cancer
      pain (sudden sharp or stabbing pain), especially when painful bone metastases are present.
      The current care for most cancer patients receiving radiation is to take an oral (by mouth)
      opioid medication before the radiation treatment. The pain relieving effects of these
      medications can take about one hour and can last for 3 to 6 hours, which does not follow the
      time course of when breakthrough cancer pain occurs.

      Lazanda is a pain medication delivered via an intranasal route and is already approved by the
      U.S. Food and Drug Administration (FDA) for the management of breakthrough cancer pain for
      patients who are already receiving opioids and who can tolerate opioids for the treatment of
      cancer pain. Lazanda is fast-acting and convenient for patients to take. The purpose of this
      study is to assess the change in pain intensity during palliative radiotherapy following
      study treatment with Lazanda. This study will also explore the impact of the study treatment
      on the efficiency in delivering the radiation therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has the ability to understand and the willingness to sign a written informed
             consent.

          2. Pathologically-confirmed solid tumor or hematologic malignancy with symptomatic bone
             metastases.

          3. Patient is planned to receive hypofractionated palliative radiation ≤ 10 fractions.

          4. Patient must be opioid-tolerant (greater than or equal to 60mg morphine or equivalent)
             and on a stable dose of oral opioids for greater than or equal to 1 week. Stable
             baseline opioid dosage defined as a dosage that does not fluctuate by more than 50%
             from the average dosage over one week prior to screening.

          5. Patient must be on a stable dose of adjuvant pain therapies for one week prior to
             screening (i.e. steroids, NSAIDs, anticonvulsants, pharmaceutical cannabinoids,
             tricyclic antidepressants).

          6. Patient is ≥ 18 years of age.

          7. Both men and women of all races and ethnic groups are eligible for this trial.

          8. ECOG Performance Status ≤ 3

          9. Women of child-bearing potential and men with partners of child-bearing potential must
             agree to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry, for the duration of study participation, and for 28
             days following completion of therapy. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

               -  A woman of child-bearing potential is any female (regardless of sexual
                  orientation, having undergone a tubal ligation, or remaining celibate by choice)
                  who meets the following criteria:

               -  Has not undergone a hysterectomy or bilateral oophorectomy; or

         10. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has
             had menses at any time in the preceding 12 consecutive months)Women of child-bearing
             potential has negative pregnancy test prior to initiating study drug dosing.

        Exclusion Criteria:

          1. Patient is currently receiving or has received another investigational agent within 30
             days or monoamine oxidase inhibitor within 14 days prior to Lazanda administration.

          2. Patients who require immobilization with a thermoplastic mask for radiation treatment.

          3. Patient is planned to receive interventional procedures (i.e. surgery) that may affect
             study outcomes.

          4. Patient has a history of hypersensitivity to fentanyl or opioids.

          5. Patient is pregnant or nursing. There is a potential for congenital abnormalities and
             for this regimen to harm nursing infants.

          6. Patient is being treated with oxymetazoline for allergic rhinitis or has a disorder or
             current medication use likely to adversely affect normal functioning of the nasal
             mucosa.

          7. Patient has uncontrolled or rapidly escalating background pain.

          8. Patient has bradyarrhythmia.

          9. Patient is considered medically unstable.

         10. Patient is thought to be at risk for misuse, abuse, addiction or overdose for Schedule
             II controlled substance, as evidenced by the following:

               1. An Opioid Risk Tool (ORT) score of greater/less than or equal to 8.

               2. A review of the California Prescription Control Monitoring Program (PDMP)
                  Controlled Substance Utilization Review and Evaluation System (CURES) report
                  demonstrates multiple prescribing providers and/or multiple pharmacies in the
                  last 30 days. The CURES report will also be used to verify opioid use, opioid
                  dose, and current prescribing providers.