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Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients. (stREnGTH)

Primary Purpose

Head Neck Cancer, Radiation Neuropathy, Pain, Neuropathic

Status
Withdrawn
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Neck Cancer focused on measuring Gabapentin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, pharynx and larynx. Cancer of the nasal cavity, nasopharynx, paranasal sinuses, parotid gland, or a T1-2N0M0 of the glottis are excluded.
  • Primary cancer eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent
  • TNM stage I to IVb, without distant metastases
  • Patients should require the intake of at least a weak opioid (inclusion starting at prescription/intake of at least a step 2 drug (e.g. a step 2 or step 3 analgesic; if a physician would decide to skip step 2) according to the WHO pain ladder)
  • Patients should be 18 or older at the time of enrolment
  • Patients should be able to adequately communicate in Dutch or French

Exclusion Criteria:

  • Patients younger than 18 years at the time of enrolment
  • Patients with cancer of the nasal cavity, nasopharynx, paranasal sinuses, parotid glands, or a T1-2N0M0 of the glottis
  • Pregnant or lactating women (Non-pregnancy must be confirmed before the first administration by use of a urine pregnancy test. Any positive urine pregnancy test must be confirmed via a serum β-HCG test).
  • Patients presenting with another non-cured cancer (e.g. PSA or CEA not within normal range as determined by the treating physician)
  • Patients with a prior history of cancer, with or without radio(chemo)therapy, diagnosed within the last 5 years
  • Patients who report post-operative pain, as judged by the investigator
  • Patients with a locoregional relapse of a prior head and neck tumour, for which they already received surgery or radio(chemo)therapy
  • Patients who received radiation therapy in the head and neck region in the past
  • Patients with (severe) dementia (DSM-IV criteria) or other significant psychiatric illnesses (e.g. mania, psychosis, schizophrenia, Korsakov, diagnosed major depression and/or history of suicide attempts) that would preclude study compliance
  • Patients taking gabapentin/pregabalin or with prior gabapentin/pregabalin use
  • Patients taking pain medications (e.g. topical analgesics such as lidocaine gel or lidocaine patch) for pre-existing pain of other aetiology. Administration of topical mouthwash is allowed.
  • Patients with pre-existing peripheral neuropathy of another aetiology, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning, syphilis, amyloidosis, hyper- or hypothyroidism, inherited neuropathy
  • Patients taking anti-epileptics for (myoclonic) seizures or neuropathic pain
  • Patients taking anti-depressants for neuropathic pain (i.e. anti-depressant described as the first and second group in the BCFI are excluded, anti-depressants of the third group or selective serotonin reuptake inhibitors (SSRI) are allowed)
  • Patients with chronic kidney failure (creatinine clearance <30 ml/min)
  • Patients with a diagnosis of acute pancreatitis within the last 6 months
  • Patients with a current active hepatic or biliary disease
  • Patients presenting with clinical signs of CNS depression
  • Patients with a hypersensitivity to the active substance
  • Patients with galactose intolerance and/or lactase deficiency

Sites / Locations

  • UZ Ghent
  • AZ Groeninge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Patients randomised to the experimental group will receive a prescription for a gabapentin starting dose of 100 mg three times a day (ter in die, t.i.d) /day per orally, additional to the analgesics according to standard local practices. Gabapentin dosage may be gradually increased based on individual patient response and tolerability, and as per standard practice in accordance with the drug label. The dose can be further increased in 300 mg/day increments (dose increments of 50% - 100%) every two to three days, up to a maximum dose of 3600 mg/day. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of two weeks, and to reach 3600 mg/day is a total of three weeks.

Patients randomised to the control group will receive a prescription for a matching placebo. The starting dose will be the same as in the experimental group (100 mg three times a day per orally), additional to the analgesics according to standard local practices. Placebo can optionally follow the same dose scheme as described in the experimental arm.

Outcomes

Primary Outcome Measures

Requirement of patients included in 7-week curative radio(chemo)therapy for a (dose-escalation of) strong opioid
Through pain diary, weekly visit by doctor and research assistant, the need for (dose-escalation of) strong opioid will be assessed.

Secondary Outcome Measures

Pain prevalence, prevalence of opioid use within HNCA patients
Through pain diary, weekly visit by doctor and research assistant, patients will be asked to rate their pain
Maintenance or amelioration of pain within subtypes measured by the 0-10 numeric visual analogue pain rating scale.
Pain assessment of subtypes of patients, according to their tumour location, through the 0-10 numeric visual analogue pain rating scale. This scale is a tool to measure the pain of patients, with a score of 0 if the patient has no pain, a score of 5 if the patient has moderate pain and a score of 10 if the patient copes with the worst possible pain. So higher values represent worse pain.
Maintenance or amelioration of pain within subtypes measured by the Neuropathic Pain Scale
Pain assessment of subtypes of patients, according to their tumour location, through the Neuropathic Pain Scale. Patients give a score between 0 until 10 on different aspects of pain as pain sharpness, heat/cold, dullness, intensity, unpleasantness, and surface vs. deep pain which all represent the subtypes of the Neuropathic Pain Scale. A score between 0 and 10 will be assigned to these different subtypes of pain, with a score of 0 if the patient has no pain, a score of 5 if the patient has moderate pain and a score of 10 if the patient copes with the worst possible pain. So higher values represent worse pain. The scores on all these subscales are not combined as we are interested in the subtypes of pain themselves.
Maintenance or amelioration of pain within subtypes measured by the Brief Pain Inventory (Short Form).
Pain assessment of subtypes of patients, according to their tumour location, through the Brief Pain Inventory (Short Form).
Effect on treatment-related toxicity (mucositis, dysphagia, fatigue, weight loss)
Treatment-related toxicities will be scored by the local physician
Effect on hospitalisation requirement
Effect on hospitalisation will be assessed by the local physician and the research assistant
Effect on percutaneous endoscopic gastrostomy tube placement
Effect on the placement of percutaneous endoscopic gastrostomy tube will be assessed by the local physician and research assistant
Difference in dose of opioids needed for pain relief between the experimental and control group
Monitoring of opioid therapy until primary endpoint
Effect on quality of life, and sleep quality in specific, of head and neck cancer patients assessed by EORTC QLQ C30
Measured by EORTC QLQ C30
Effect on quality of life, and sleep quality in specific, of head and neck cancer patients assessed by HN35 Questionnaires
Measured by HN35 Questionnaires
Effect on quality-adjusted life years
Measured by EuroQoL
Drug tolerance
Monitoring of drug tolerance by local physician on weekly visits. The effects of the drug can either be unchanged, lessened, or increased. According to this, the physician will adapt the dose for patient. This will be weekly reported by the local physician to the research associate.
(S)AE
Monitoring of drug safety by local physician according to treatment-related toxicities, scored weekly by the local physicians according to the Common Terminology Criteria of Adverse Events (NCI CTCAE 5.0). Analgesic-induced side effects will be evaluated with regard to nausea, constipation, sleepiness, dizziness, confusion, hypersensitivities, urinary retention, pruritus and respiratory depression.
Acceptance rate of gabapentin
Weekly monitoring of drug compliance by local physician and research associate. Research associate counts amount of medication (gelules) that are left to assure there is therapy compliance.
Ease of use of trial medication
Through pain diary, weekly visit by research assistant, patients will be asked about the ease of use of trial medication
Study drop-out
Continuous follow-up of patients (weekly or daily) by research assistant
Patient satisfaction
Through weekly visit by research assistant, patients will be asked how satisfied they are with current trial medication
Selection of biomarkers to identify patients prone to develop HN cancer pain/treatment-related pain
Patients will be able to agree or disagree with the collection of blood samples on the informed consent form as these translational aspects are not an obligatory part of this trial. In patients who give their consent, one SST blood sample and one EDTA blood sample will be collected at the time of inclusion.
Selection of biomarkers to select patients who benefit more from analgesic treatment with gabapentin
Patients will be able to agree or disagree with the collection of blood samples on the informed consent form as these translational aspects are not an obligatory part of this trial. In patients who give their consent, one SST blood sample and one EDTA blood sample will be collected at the time of inclusion.

Full Information

First Posted
October 9, 2018
Last Updated
December 16, 2022
Sponsor
University Hospital, Ghent
Collaborators
General Hospital Groeninge, KU Leuven Campus Kulak Kortrijk, Anglia Ruskin University
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1. Study Identification

Unique Protocol Identification Number
NCT03747562
Brief Title
Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.
Acronym
stREnGTH
Official Title
Multi-centre, Double-blind, Randomized-controlled Trial to Study the Efficacy and Safety of Gabapentin to Reduce Strong Opioid Use in Treatment of Radiation-induced Pain in Head and Neck Cancer Patients During Curative Radio(Chemo)Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
General Hospital Groeninge, KU Leuven Campus Kulak Kortrijk, Anglia Ruskin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
A multi-centre, double-blind, randomized-controlled trial to study the efficacy and safety of gabapentin to reduce the need for strong opioid use in the treatment of radiation-induced pain in head and neck cancer (HNCA) patients undergoing a curative 7-week radio(chemo)therapy course with curative intent. The aim of this study is to establish if addition of gabapentin is more effective in reducing the need to start (or dosage-increase) a strong opioid for HNCA pain than a matching placebo additional to standard pain management (WHO-ladder step 2 and 3).
Detailed Description
Although pain is a major symptom in head and neck cancer (HNCA) patients, few studies focus on pain management in this population. Current optimal HNCA pain control usually requires the use of a strong opioid (WHO-ladder step 3), increasing the risk of opioid side effects and toxicities. Gabapentin, originally an anticonvulsant drug, has been effectively used off-label to treat multiple neuropathic pain syndromes such as cancer pain, and has been suggested to reduce the need for high doses of strong opioids in HNCA patients under radio(chemo)therapy. A multi-centre, phase III, double-blind, randomised-controlled trial will be set up randomising patients between the experimental group (E) receiving gabapentin, or the control group (C) receiving a matching placebo, both in addition to standard analgesic therapy (steps 2 and 3 on WHO-ladder). The investigators aim to establish if addition of gabapentin is more effective in reducing the need to start (or dosage-increase) a strong opioid for HNCA pain than a matching placebo additional to standard pain management (WHO-ladder step 2 and 3), in HNCA patients scheduled for a curative 7-week radio(chemo)therapy course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Cancer, Radiation Neuropathy, Pain, Neuropathic
Keywords
Gabapentin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised-controlled trial where patients are randomised to either the experimental group (E) receiving gabapentin or the control group (C) receiving a matching placebo, both in addition to standard analgesic therapy (WHO ladder steps 2 and 3).
Masking
ParticipantCare ProviderInvestigator
Masking Description
Both patient groups will receive gabapentin or a matching placebo additional to the standard analgesic therapy, and will be asked to consume the content following the predefined directions provided to them. Both the investigators and the patients will be blinded for the IMP, since gabapentin and the matching placebo will appear identical. The clinical pharmacist responsible for clinical trials as well as Bimetra clinics will receive a sealed envelope from the statistician with the information necessary for decoding.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients randomised to the experimental group will receive a prescription for a gabapentin starting dose of 100 mg three times a day (ter in die, t.i.d) /day per orally, additional to the analgesics according to standard local practices. Gabapentin dosage may be gradually increased based on individual patient response and tolerability, and as per standard practice in accordance with the drug label. The dose can be further increased in 300 mg/day increments (dose increments of 50% - 100%) every two to three days, up to a maximum dose of 3600 mg/day. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of two weeks, and to reach 3600 mg/day is a total of three weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients randomised to the control group will receive a prescription for a matching placebo. The starting dose will be the same as in the experimental group (100 mg three times a day per orally), additional to the analgesics according to standard local practices. Placebo can optionally follow the same dose scheme as described in the experimental arm.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin will be administrated orally, with or without food, and should be swallowed with sufficient fluid intake (e.g. a glass of water). Since head and neck cancer patients frequently experience swallowing difficulties, gabapentin capsules will be provided to enable opening of the capsule and use of the contents for mixture with food or liquids. Moreover, gabapentin powder can be dissolved in water to enable injection of the drug into a percutaneous endoscopic gastrostomy tube.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administrated orally, with or without food, and should be swallowed with sufficient fluid intake (e.g. a glass of water). Since head and neck cancer patients frequently experience swallowing difficulties, placebo capsules will be provided to enable opening of the capsule and use of the contents for mixture with food or liquids. Moreover, placebo powder can be dissolved in water to enable injection of the drug into a percutaneous endoscopic gastrostomy tube.
Primary Outcome Measure Information:
Title
Requirement of patients included in 7-week curative radio(chemo)therapy for a (dose-escalation of) strong opioid
Description
Through pain diary, weekly visit by doctor and research assistant, the need for (dose-escalation of) strong opioid will be assessed.
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Secondary Outcome Measure Information:
Title
Pain prevalence, prevalence of opioid use within HNCA patients
Description
Through pain diary, weekly visit by doctor and research assistant, patients will be asked to rate their pain
Time Frame
Daily, weekly and assessed at visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Maintenance or amelioration of pain within subtypes measured by the 0-10 numeric visual analogue pain rating scale.
Description
Pain assessment of subtypes of patients, according to their tumour location, through the 0-10 numeric visual analogue pain rating scale. This scale is a tool to measure the pain of patients, with a score of 0 if the patient has no pain, a score of 5 if the patient has moderate pain and a score of 10 if the patient copes with the worst possible pain. So higher values represent worse pain.
Time Frame
Daily, weekly and assessed at visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Maintenance or amelioration of pain within subtypes measured by the Neuropathic Pain Scale
Description
Pain assessment of subtypes of patients, according to their tumour location, through the Neuropathic Pain Scale. Patients give a score between 0 until 10 on different aspects of pain as pain sharpness, heat/cold, dullness, intensity, unpleasantness, and surface vs. deep pain which all represent the subtypes of the Neuropathic Pain Scale. A score between 0 and 10 will be assigned to these different subtypes of pain, with a score of 0 if the patient has no pain, a score of 5 if the patient has moderate pain and a score of 10 if the patient copes with the worst possible pain. So higher values represent worse pain. The scores on all these subscales are not combined as we are interested in the subtypes of pain themselves.
Time Frame
Daily, weekly and assessed at visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Maintenance or amelioration of pain within subtypes measured by the Brief Pain Inventory (Short Form).
Description
Pain assessment of subtypes of patients, according to their tumour location, through the Brief Pain Inventory (Short Form).
Time Frame
Daily, weekly and assessed at visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Effect on treatment-related toxicity (mucositis, dysphagia, fatigue, weight loss)
Description
Treatment-related toxicities will be scored by the local physician
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Effect on hospitalisation requirement
Description
Effect on hospitalisation will be assessed by the local physician and the research assistant
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Effect on percutaneous endoscopic gastrostomy tube placement
Description
Effect on the placement of percutaneous endoscopic gastrostomy tube will be assessed by the local physician and research assistant
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Difference in dose of opioids needed for pain relief between the experimental and control group
Description
Monitoring of opioid therapy until primary endpoint
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Effect on quality of life, and sleep quality in specific, of head and neck cancer patients assessed by EORTC QLQ C30
Description
Measured by EORTC QLQ C30
Time Frame
Visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Effect on quality of life, and sleep quality in specific, of head and neck cancer patients assessed by HN35 Questionnaires
Description
Measured by HN35 Questionnaires
Time Frame
Visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Effect on quality-adjusted life years
Description
Measured by EuroQoL
Time Frame
Visit 1 (moment of inclusion), visit 2 (anticipated week 5), visit 3 (end of radio(chemo)therapy), and week 24 (follow-up)
Title
Drug tolerance
Description
Monitoring of drug tolerance by local physician on weekly visits. The effects of the drug can either be unchanged, lessened, or increased. According to this, the physician will adapt the dose for patient. This will be weekly reported by the local physician to the research associate.
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
(S)AE
Description
Monitoring of drug safety by local physician according to treatment-related toxicities, scored weekly by the local physicians according to the Common Terminology Criteria of Adverse Events (NCI CTCAE 5.0). Analgesic-induced side effects will be evaluated with regard to nausea, constipation, sleepiness, dizziness, confusion, hypersensitivities, urinary retention, pruritus and respiratory depression.
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Acceptance rate of gabapentin
Description
Weekly monitoring of drug compliance by local physician and research associate. Research associate counts amount of medication (gelules) that are left to assure there is therapy compliance.
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Ease of use of trial medication
Description
Through pain diary, weekly visit by research assistant, patients will be asked about the ease of use of trial medication
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Study drop-out
Description
Continuous follow-up of patients (weekly or daily) by research assistant
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Patient satisfaction
Description
Through weekly visit by research assistant, patients will be asked how satisfied they are with current trial medication
Time Frame
Continuous monitoring from patient enrollment until week 7 or date of requiring a (dose-escalation of) strong opioid if this occurs before week 7 (end of radio(chemo)therapy)
Title
Selection of biomarkers to identify patients prone to develop HN cancer pain/treatment-related pain
Description
Patients will be able to agree or disagree with the collection of blood samples on the informed consent form as these translational aspects are not an obligatory part of this trial. In patients who give their consent, one SST blood sample and one EDTA blood sample will be collected at the time of inclusion.
Time Frame
At time of patient enrollment
Title
Selection of biomarkers to select patients who benefit more from analgesic treatment with gabapentin
Description
Patients will be able to agree or disagree with the collection of blood samples on the informed consent form as these translational aspects are not an obligatory part of this trial. In patients who give their consent, one SST blood sample and one EDTA blood sample will be collected at the time of inclusion.
Time Frame
At time of patient enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, pharynx and larynx. Cancer of the nasal cavity, nasopharynx, paranasal sinuses, parotid gland, or a T1-2N0M0 of the glottis are excluded. Primary cancer eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent TNM stage I to IVb, without distant metastases Patients should require the intake of at least a weak opioid (inclusion starting at prescription/intake of at least a step 2 drug (e.g. a step 2 or step 3 analgesic; if a physician would decide to skip step 2) according to the WHO pain ladder) Patients should be 18 or older at the time of enrolment Patients should be able to adequately communicate in Dutch or French Exclusion Criteria: Patients younger than 18 years at the time of enrolment Patients with cancer of the nasal cavity, nasopharynx, paranasal sinuses, parotid glands, or a T1-2N0M0 of the glottis Pregnant or lactating women (Non-pregnancy must be confirmed before the first administration by use of a urine pregnancy test. Any positive urine pregnancy test must be confirmed via a serum β-HCG test). Patients presenting with another non-cured cancer (e.g. PSA or CEA not within normal range as determined by the treating physician) Patients with a prior history of cancer, with or without radio(chemo)therapy, diagnosed within the last 5 years Patients who report post-operative pain, as judged by the investigator Patients with a locoregional relapse of a prior head and neck tumour, for which they already received surgery or radio(chemo)therapy Patients who received radiation therapy in the head and neck region in the past Patients with (severe) dementia (DSM-IV criteria) or other significant psychiatric illnesses (e.g. mania, psychosis, schizophrenia, Korsakov, diagnosed major depression and/or history of suicide attempts) that would preclude study compliance Patients taking gabapentin/pregabalin or with prior gabapentin/pregabalin use Patients taking pain medications (e.g. topical analgesics such as lidocaine gel or lidocaine patch) for pre-existing pain of other aetiology. Administration of topical mouthwash is allowed. Patients with pre-existing peripheral neuropathy of another aetiology, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning, syphilis, amyloidosis, hyper- or hypothyroidism, inherited neuropathy Patients taking anti-epileptics for (myoclonic) seizures or neuropathic pain Patients taking anti-depressants for neuropathic pain (i.e. anti-depressant described as the first and second group in the BCFI are excluded, anti-depressants of the third group or selective serotonin reuptake inhibitors (SSRI) are allowed) Patients with chronic kidney failure (creatinine clearance <30 ml/min) Patients with a diagnosis of acute pancreatitis within the last 6 months Patients with a current active hepatic or biliary disease Patients presenting with clinical signs of CNS depression Patients with a hypersensitivity to the active substance Patients with galactose intolerance and/or lactase deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Boterberg, MD, PhD
Organizational Affiliation
Head of Clinic, Radiation Oncologist Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Ghent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.

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