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
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/12/2019 |
| Start Date: | January 2015 |
| End Date: | July 2020 |
| Contact: | VICC Clinical Trials Information Program |
| Phone: | 800-811-8480 |
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.
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.
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.
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
We found this trial at
1
site
Nashville, Tennessee 37232
Principal Investigator: Derek Smith, DDS, PhD
Phone: 800-811-8480
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