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Table 4 World Health Organization tial registration dataset

From: Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial

Item Description
Primary registry and trial identifying number NCT04221165
Date of registration in primary registry January 9, 2020
Secondary identifying numbers N/A
Source(s) of monetary or material support PSI Foundation Resident Research Grant
Primary sponsor Lawson Health Research Institute
Secondary sponsor(s) N/A
Contact for public queries Dr. David A. Palma
Contact for scientific queries Dr. David A. Palma
Public title Opioid Therapy vs. Multimodal Analgesia in Head and Neck Cancer (OPTIMAL-HN)
Scientific title Opioid Therapy vs. Multimodal Analgesia in Head and Neck Cancer (OPTIMAL-HN): A Randomized Clinical Trial
Countries of recruitment Canada
Health condition(s) or problem(s) studied Head and Neck Cancer Radiation-Induced Mucositis Pain
Intervention(s) Multimodal Analgesia (Pregabalin, Acetaminophen, Naproxen ± Opioid), or Opioid Analgesia alone
Key inclusion and exclusion criteria Inclusion Criteria:
1. Age 18 years or older
2. Willing to provide consent
3. Histologically confirmed mucosal head and neck malignancy
4. Undergoing chemoradiotherapy or radiotherapy alone with a planned total radiation dose of 50 Gy or greater
5. Eastern Cooperative Oncology Group (ECOG) performance status 0–2
6. Life expectancy > 6 months
7. Onset of 4/10 pain on the 11-Numeric Rating Scale that is localized to the mucosa of the mouth or throat, before or during radiation treatment, that is not caused by a current oral candidiasis infection.
8 Ability to take pills, either by mouth or crushed via nasogastric (NG) tube or gastrostomy (G) tube
9. Ability to complete the study questionnaires and pain diary
10. Ability to sign consent without requirement for a substitute decision maker
Exclusion Criteria:
1. Skin and salivary gland malignancies
2. High daily opioid use (defined as 30 mg oral morphine equivalent dose or higher) for more than 7 days at time of enrollment
3. Concurrent second active malignancy
4. Pregnant or lactating women
5. Psychological disorder requiring pharmacologic treatment
6. Regular systemic steroid use
7. Regular anticonvulsant or antidepressant use
8. Renal Impairment
◦ Defined as creatinine clearance < 60 mL/min
9. Liver Dysfunction
◦ Defined as total bilirubin > 34.2 μmol/L
10. Documented true allergy to Acetaminophen, NSAIDs, Pregabalin or opioids
11. History of upper gastrointestinal bleed
12. Known bleeding disorder
13. History of or current substance use disorder
Study type Randomized by permuted blocks sequence
No masking/blinding (open label)
Parallel 1:1 assignment
Date of first enrolment August 25, 2020
Target sample size 62
Recruitment status Recruiting
Primary outcome(s) Average 11-NRS for pain during last week of radiation treatment
Key secondary outcomes Average weekly opioid use, duration of opioid requirement, average daily 11-NRS for pain, average weekly opioids dispensed, hospitalizations, time to feeding tube insertion, weight loss, toxicity, treatment interruptions, and death within 3 months of treatment completion.