Intranasal (NAS) Ketamine for Cancer Pain

• Status: Completed
• Trial end date: 2020-04-22
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to determine the safety, feasibility, and utility of intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective clinical trial the researchers will investigate the use of NAS ketamine in patients with pain related to cancer or cancer treatment. The researchers plan to enroll at least 25 patients meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the study. Participants will be recruited from the supportive oncology clinic, oncology clinics, the pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five days apart. During these visits participants will complete questionnaires, have blood samples drawn and will have study medication administered to them in escalating doses. For safety monitoring participants will be contacted by telephone 14 days after the last dose of medication administered.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Patients with uncontrolled pain related to cancer or cancer treatment. Uncontrolled pain will be defined as:

• Pain which persists for more than 7 days and is rated >/=4 on Numerical Pain Rating Score (NPRS)

• Use of breakthrough medication more than 4 times in 24 hours or being treated with oral morphine equivalent of 50 mg/d or more

• Patients who are able to follow-up in person during the trial

• Patient on stable analgesic regimen for >7 days without escalation during study period with rescue or immediate release medication every 3 hours or longer

• Patients who are willing and able to maintain a daily pain diary

• Patients who are able to understand written and verbal English

• Patient weight >/= 50 kg

Exclusion Criteria:

• Transportation issues interfering with return study visits

• Patients with high disposition of laryngospasm or apnea

• Presence of severe cardiac disease

• Presence of conditions where significant elevations in blood pressure would be a serious hazard.

• Stage 2 hypertension or greater (systolic blood pressure > 160 and/or diastolic blood pressure >100)

• Baseline tachycardia, heart rate (HR) >100

• History of seizures, elevated intracranial pressure (ICP) or cerebrospinal fluid (CSF) obstructive states (e.g. severe head injury, central congenital or mass lesions)

• Conditions that may increase intraocular pressure (e.g. glaucoma, acute globe injury)

• History of uncontrolled depression or other psychiatric comorbidity with psychosis

• History of liver disease

• History of interstitial cystitis

• History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis.

• Patients with lesions to the nasal mucosa

• Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective. Highly effective contraception methods include combination of any two of the following:

• Use of oral, injected or implanted hormonal methods of contraception or;

• Placement of an intrauterine device (IUD) or intrauterine system (IUS);

• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;

• Total abstinence or;

• Male/female sterilization.

• Illicit substance abuse within the past 6 months

• Documented history of medication abuse/misuse (e.g. Unsanctioned dose escalation, broken opioid agreement etc.)

• Clinical requirement for medications that are concurrent inducers or inhibitors of CYP3A4. CYP3A4 substrates are allowed.

• Porphyria (possibility of triggering a porphyric reaction)

• Severe active anemia ( a hemoglobin< 8 documented by labs drawn within 3 months of first study treatment)

• History of difficult intravenous access

• Intractable vomiting