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Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT04221165
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Ontario Institute for Cancer Research
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation-Induced Mucositis Drug: Opioids Drug: PAiN - multimodal analgesia Phase 2

Detailed Description:

A significant proportion of patients undergoing radiotherapy alone or chemotherapy and radiotherapy together for their head and neck cancer experience mucositis, which is severe pain in the mouth and throat caused by radiation treatment. Patients often enter a cycle of pain, difficulty swallowing, malnourishment, and reduced quality of life. This may translate into decreased oral intake requiring a feeding tube, and radiation or chemotherapy treatment breaks, which reduce the chance of tumour control and cure.

Currently, opioid therapy is the cornerstone of head and neck cancer pain management. Although effective for pain relief, opioids can have side effects.

As an alternative to opioid treatments, "multimodal analgesia" is a treatment using medications from different classes with different mechanisms of action. Examples of analgesic medications used for multimodal analgesia include medications similar to acetaminophen or ibuprofen, and others.

The primary purpose of this study is to compare pain level scores of patients taking opioids versus patients taking multimodal analgesia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer: A Randomized Clinical Trial
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Opioid Analgesia
Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone.
 Drug: Opioids
Opioids will be prescribed as per institutional standards.
Experimental: Multimodal Analgesia
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
PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium


Outcome Measures
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Primary Outcome Measures :
  1. Average Pain Rating measured on the 11 Numeric Rating Scale [ Time Frame: Approximately 2 years and 3 months ]
    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.


Secondary Outcome Measures :
  1. Average Weekly Opioid Use [ Time Frame: Approximately 2 years and 4 months ]
    The average weekly total opioid dose in oral morphine equivalent dosing from randomization to 6 weeks after completion of radiation treatment.

  2. Duration of Opioid Requirement [ Time Frame: Approximately 2 years and 6 months ]
    The time from the start of opioid treatment after randomization to the time of stopping opioid analgesia, in days.

  3. Average Daily 11-Numeric Rating Scale for Pain [ Time Frame: Approximately 2 years and 4 months ]
    Average pain rating from the time of randomization until 6 weeks after completion of radiation treatment, 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.

  4. Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) [ Time Frame: Approximately 24 months, 27 months, and 30 months ]
    Quality of life, as reported by the patient, will be assessed using the EORTC QLQ-C30 validated questionnaire. Responses regarding function and symptoms are on a scale of 1 (not at all) to 4 (very much). Also included are questions about overall health and quality of life. Responses are on a scale of 1 (very poor) to 7 (excellent).

  5. 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) [ Time Frame: Approximately 24 months, 27 months, and 30 months ]
    Quality of life, as reported by the patient, will be assessed using the EORTC QLQ-HN 43 validated questionnaire. Responses regarding symptoms or problems are on a scale of 1 (not at all) to 4 (very much). This questionnaire is specifically for patients with head and neck cancer.

  6. Average Weekly Opioids Dispensed [ Time Frame: Approximately 2 years and 4 months ]
    The average weekly total opioid dose dispensed by the pharmacy in oral morphine equivalent dosing from randomization to 6 weeks after completion of radiation treatment.

  7. Hospital Admissions [ Time Frame: Approximately 27 months and 30 months ]
    Hospital admissions for febrile neutropenia, serious infection requiring intravenous antibiotics, gastrointestinal bleeding, myocardial infarction, stroke, and acute kidney injury.

  8. Time to Feeding Tube Insertion [ Time Frame: Approximately 2 years and 3 months ]
    The time to feeding tube insertion (e.g. gastrostomy-tube or nasogastric-tube) after randomization, in days.

  9. Weight Loss [ Time Frame: Approximately 2 years and 3 months ]
    Weight loss from randomization to the end of radiation treatment.

  10. Rates of Common Terminology Criteria for Adverse Events Toxicities [ Time Frame: Approximately 2 years and 6 months ]
    Rates of pre-specified Common Terminology Criteria for Adverse Events (CTCAE) toxicities.

  11. Treatment Interruptions [ Time Frame: Approximately 2 years and 6 months ]
    Number of participants with radiation of chemotherapy treatment interruptions.

  12. Death [ Time Frame: Approximately 2 years and 6 months ]
    Number of participants who die during or within 3 months after completion of radiation treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221165


Contacts
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Contact: David Palma, MD 519-685-8650 David.Palma@lhsc.on.ca
Contact: Sondos Zayed, MD 519-685-8650 Sondos.Zayed@lhsc.on.ca

Locations
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Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David Palma, MD    519-685-8650    David.Palma@lhsc.on.ca   
Principal Investigator: David Palma, MD, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Institute for Cancer Research
Investigators
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Principal Investigator: David Palma, MD Lawson Health Research Institute
More Information
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Publications:

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04221165    
Other Study ID Numbers: OPTIMAL HN
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Pain
Analgesia
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
 Stomatognathic Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents