Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer

NCT04221165 | Completed Phase 2

• 1 other identifier: OPTIMAL HN
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the daily pain level scores for patients taking opioids alone for pain relief, compared with those treated by multimodal analgesia with three medications: pregabalin, naproxen, and acetaminophen, with the ability to switch over to opioid medications if needed. In addition to pain level scores, this study will compare opioid use (length of time and doses taken), quality of life, admissions to hospital, feeding tube requirements, weight loss, and treatment interruptions between these two analgesic regimens.

Conditions

Head and Neck Cancer; Radiation-Induced Mucositis

Keywords

Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Average Pain Rating measured on the 11 Numeric Rating Scale

  Average pain rating during the last 7 days of radiation therapy, as reported by the patient on the 11-Numeric Rating Scale (11-NRS). On the 11-NRS, zero (0) is no pain, and ten (10) is the worst possible pain.

  Approximately 2 years and 3 months

Secondary Outcomes (12)

• Average Weekly Opioid Use

  Approximately 2 years and 4 months

• Duration of Opioid Requirement

  Approximately 2 years and 6 months

• Average Daily 11-Numeric Rating Scale for Pain

  Approximately 2 years and 4 months

• Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

  Approximately 24 months, 27 months, and 30 months

• Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head & Neck 43 (EORTC QLQ-HN 43)

  Approximately 24 months, 27 months, and 30 months

Study Arms (2)

Opioid Analgesia

ACTIVE COMPARATOR

Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone.

Drug: Opioids

Multimodal Analgesia

EXPERIMENTAL

Pregabalin (50 mg to 300 mg, oral, twice daily), acetaminophen (1000 mg, oral, 3 times per day), naproxen 250 mg to 500 mg, oral, twice daily), and pantoprazole magnesium (40 mg, oral, daily)

Drug: PAiN - multimodal analgesia

Interventions

Opioids DRUG

Opioids will be prescribed as per institutional standards.

Opioid Analgesia

PAiN - multimodal analgesia DRUG

PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium

Multimodal Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Willing to provide consent
• Histologically confirmed mucosal head and neck malignancy
• Undergoing chemoradiotherapy or radiotherapy alone with a planned total radiation dose of 50 Gray (Gy) or greater
• Eastern Co-operative Oncology Group (ECOG) performance status 0-2
• Life expectancy \> 6 months
• 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.
• Ability to take pills, either by mouth or crushed via NasoGastric (NG) tube or Gastrostomy tube (G-tube)
• Ability to complete the study questionnaires and pain diary
• Ability to sign consent without requirement for a substitute decision maker

You may not qualify if:

• Skin and salivary gland malignancies
• High daily opioid use at time of enrollment (defined as 30 mg oral morphine equivalent dose or higher)
• Concurrent second active malignancy
• Pregnant or lactating women
• Psychological disorder requiring pharmacologic treatment
• Regular systemic steroid use
• Regular anticonvulsant or antidepressant use
• Renal Impairment (defined as creatinine clearance \< 60 mL/min)
• Liver Dysfunction (defined as total bilirubin \> 34.2 µmol/L)
• Documented true allergy to acetaminophen, NSAIDs, pregabalin or opioids
• History of upper gastrointestinal bleed
• Known bleeding disorder
• History of or current substance use disorder

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (1)

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

Related Publications (6)

• Elad S, Yarom N. The Search for an Effective Therapy and Pain Relief for Oral Mucositis. JAMA. 2019 Apr 16;321(15):1459-1461. doi: 10.1001/jama.2019.3269. No abstract available.

  PMID: 30990535 BACKGROUND

• Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou-Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25.

  PMID: 24615748 BACKGROUND

• Mirabile A, Airoldi M, Ripamonti C, Bolner A, Murphy B, Russi E, Numico G, Licitra L, Bossi P. Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Crit Rev Oncol Hematol. 2016 Mar;99:100-6. doi: 10.1016/j.critrevonc.2015.11.010. Epub 2015 Dec 3.

  PMID: 26712589 BACKGROUND

• Alfieri S, Ripamonti CI, Marceglia S, Orlandi E, Iacovelli NA, Granata R, Cavallo A, Pozzi P, Boffi R, Bergamini C, Imbimbo M, Pala L, Resteghini C, Mirabile A, Locati LD, Licitra L, Bossi P. Temporal course and predictive factors of analgesic opioid requirement for chemoradiation-induced oral mucositis in oropharyngeal cancer. Head Neck. 2016 Apr;38 Suppl 1:E1521-7. doi: 10.1002/hed.24272. Epub 2016 Feb 5.

  PMID: 26849016 BACKGROUND

• Zayed S, Lang P, Read N, Correa RJM, Mutsaers A, Goodman CD, D'Angelo K, Kieraszewicz K, Vanwynsberghe D, Kingsbury-Paul A, Crewdson K, Neeb J, Carreau C, Winquist E, Kuruvilla S, Stewart P, Moulin DE, Warner A, Palma DA. Opioid therapy vs. Multimodal analgesia in head and neck cancer (OPTIMAL-HN): Results of a randomized clinical trial. Radiother Oncol. 2025 May;206:110831. doi: 10.1016/j.radonc.2025.110831. Epub 2025 Mar 5.

  PMID: 40054624 DERIVED

• Zayed S, Lang P, Mendez LC, Read N, Sathya J, Venkatesan V, Moulin DE, Warner A, Palma DA. Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial. BMC Palliat Care. 2021 Mar 19;20(1):45. doi: 10.1186/s12904-021-00735-0.

  PMID: 33740977 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Pain; Agnosia

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• David Palma, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: August 4, 2020
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)