Table 4 World Health Organization tial registration dataset
Item | Description |
|---|---|
Primary registry and trial identifying number | |
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. |