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Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy

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ClinicalTrials.gov Identifier: NCT02480114
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Derek Smith, Vanderbilt-Ingram Cancer Center

Brief Summary:
This randomized phase III trial studies how well gabapentin plus standard of care work compares to standard of care without Gabapentin in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and neck may cause a burn involving the inside of the mouth, throat, and nasal passages, resulting in pain. Gabapentin may help prevent (or minimize) pain associated with radiation-induced mucositis in patients with head and neck cancer.

Condition or disease Intervention/treatment Phase
Malignant Head and Neck Neoplasm Mucositis Radiation-Induced Disorder Other: Educational Intervention Drug: Gabapentin Other: Pain Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Oxycodone/Acetaminophen Drug: Hydrocodone/Acetaminophen Drug: Fentanyl Drug: Ibuprofen Drug: Magic Mouthwash Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether gabapentin used as a preventive measure during chemoradiation can reduce radiation-induced mucositis associated pain in head and neck cancer patients as measured by: 1) pain scores on the Vanderbilt Head and Neck Symptom Survey (VHNSS version 2.), and 2) analgesic use.

II. To determine whether pain control is associated with weight loss (in pounds) and duration of use of percutaneous endoscopic gastrostomy utilization (in days).

III. To assess the safety (grade 3 or 4 adverse events) and tolerability of using gabapentin (discontinuation of drug due to side effects - yes or no).

IV. To correlate pain severity with frequency and severity of general systemic symptoms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Standard of Care (usual care) - Patients receive consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of chemoradiation treatment to review foundations of oral care and pain management.

ARM II: Standard of Care plus Gabapentin - Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin orally (PO) three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.

After completion of study treatment, patients are followed up monthly for 3 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm I Standard of Care
Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.
Other: Educational Intervention
Undergo oral care and pain management education session
Other Name: Education for Intervention

Other: Pain Therapy
Receive usual oral health care
Other Names:
  • Analgesia
  • Pain Control
  • Pain Management
  • Pain

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Oxycodone/Acetaminophen
Analgesia
Other Name: Percocet

Drug: Hydrocodone/Acetaminophen
Analgesia
Other Names:
  • Lortab
  • Vicodin

Drug: Fentanyl
Transdermal Analgesia
Other Name: Duragesic

Drug: Ibuprofen
NSAID Analgesia
Other Names:
  • Motrin
  • Advil

Drug: Magic Mouthwash
Oral Solution to treat mucositis
Other Names:
  • Miracle Mouthwash
  • First-Mouthwash BLM
  • First-BXN Mouthwash

Active Comparator: Arm II Standard of Care Plus Gabapentin
Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.
Other: Educational Intervention
Undergo oral care and pain management education session
Other Name: Education for Intervention

Drug: Gabapentin
Given PO
Other Names:
  • Gralise
  • Neurontin
  • 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3,

Other: Pain Therapy
Receive usual oral health care
Other Names:
  • Analgesia
  • Pain Control
  • Pain Management
  • Pain

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Oxycodone/Acetaminophen
Analgesia
Other Name: Percocet

Drug: Hydrocodone/Acetaminophen
Analgesia
Other Names:
  • Lortab
  • Vicodin

Drug: Fentanyl
Transdermal Analgesia
Other Name: Duragesic

Drug: Ibuprofen
NSAID Analgesia
Other Names:
  • Motrin
  • Advil

Drug: Magic Mouthwash
Oral Solution to treat mucositis
Other Names:
  • Miracle Mouthwash
  • First-Mouthwash BLM
  • First-BXN Mouthwash




Primary Outcome Measures :
  1. Duration of use of percutaneous endoscopic gastrostomy utilization (in days) [ Time Frame: Up to 3 months post-treatment ]
    Whether pain control is associated with duration of use of percutaneous endoscopic gastrostomy utilization will be determined. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome.

  2. Frequency and severity of general systemic symptoms (surveys such as the Neurotoxicity Scale, Profile of Mood States, and Quality of life Form) [ Time Frame: Up to 3 months post-treatment ]
    Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome.

  3. Incidence of grade 3 or 4 adverse events, (graded using Common Terminology Criteria for Adverse Events criteria 4.0) [ Time Frame: Up to 3 months post-treatment ]
    Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome.

  4. Reduction of pain associated with radiation-induced mucositis, (measured by pain scores on the VHNSS version 2 and analgesic use) [ Time Frame: Up to 3 months post-treatment ]
    Graphical and descriptive statistical summaries will be generated. Evaluation of the key outcome variable data distributions (VHNSS mouth pain scores, opioid dose) will inform the required test distribution (e.g., normal, log-normal). Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome.

  5. Tolerability of using gabapentin, (measured by discontinuation of drug due to side effects) [ Time Frame: Up to 3 months post-treatment ]
    Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the tolerability outcome.

  6. Weight loss (in pounds) [ Time Frame: Up to 3 months post-treatment ]
    Whether pain control is associated with weight loss will be determined. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven cancer of the head and neck cancer
  • Stage 3 or 4
  • Planned primary or adjuvant chemoradiation therapy
  • Willing and able to provide informed consent
  • English speaking

Exclusion Criteria:

  • Currently on gabapentin
  • Prior non-tolerance of gabapentin
  • History of seizure disorder

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): NCT02480114


Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program    800-811-8480    cip@vanderbilt.edu   
Principal Investigator: Derek Smith, DDS, PhD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Derek Smith, DDS,PhD Vanderbilt University/Ingram Cancer Center

Responsible Party: Derek Smith, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02480114     History of Changes
Other Study ID Numbers: VICC HN 1541
NCI-2015-00750 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VICC HN 1541 ( Other Identifier: Vanderbilt University/Ingram Cancer Center )
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Fentanyl
Oxycodone
Hydrocodone
Acetaminophen, hydrocodone drug combination
Acetaminophen
Ibuprofen
Gabapentin
gamma-Aminobutyric Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Antipyretics