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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

June 16, 2015
June 24, 2015
December 8, 2017
January 2015
December 2018   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT02480114 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Malignant Head and Neck Neoplasm
  • Mucositis
  • Radiation-Induced Disorder
  • 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
  • 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.
    Interventions:
    • Other: Educational Intervention
    • Other: Pain Therapy
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Drug: Oxycodone/Acetaminophen
    • Drug: Hydrocodone/Acetaminophen
    • Drug: Fentanyl
    • Drug: Ibuprofen
    • Drug: Magic 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.
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
March 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
 
NCT02480114
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 )
Yes
Not Provided
Not Provided
Derek Smith, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Derek Smith, DDS,PhD Vanderbilt University/Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP