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High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer

ConditionsHead and Neck Squamous Cell CarcinomaStage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology

About this trial

This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.

No prior treatment for head and neck cancer

Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks [q 3 week])

Able to swallow capsules whole

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gabapentin

    Drug

    Given PO

  • Placebo

    Drug

    Given PO

  • Chemotheraphy

    Drug

    Receive standard of care chemotherapy

  • Radiation Therapy

    Radiation

    Undergo standard of care radiation

  • Analgesic Agent

    Drug

    Receive standard of care pain medication

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Arm I (Placebo)Placebo comparator 6 interventions
Group B: Arm II (Gabapentin)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Need to use opioids during chemoradiation therapy (CRT)

Will be tested using a two-sample test of proportions. Will report the proportion of patients not using opioids within the 7 weeks of CRT in the two arms and the 95% confidence interval (CI) of the difference in the proportions.

Time frame
Up to 7 weeks

Secondary outcomes

1

Time to first opioid use

Time to first opioid use, defined as the time from randomization to the first occurrence of opioid use during CRT, censoring patients alive and opioid free at CRT completion. Death or disease progression before first opioid use during CRT will be treated as competing events. Cumulative incidence functions will be used to estimate the percentage of patients who experience the competing events within the arms. Differences between the cumulative incidence functions between the arms will be tested for statistical significance using the procedure of Gray. The cumulative incidence percentage at the end of CRT by arm will be reported.

Time frame
Up to 9 weeks
2

Patient-reported pain scores

Pain score responses of question #5 on the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN) survey at each collected timepoint for each arm. This NRS item asks a respondent to rate their overall mouth and throat soreness during the past week from 0 (no soreness) to 10 (worst possible soreness). Will apply longitudinal modeling of the patient-reported pain scores through four weeks post CRT treatment. Will report each time-specific comparison between arms with a 95% CI.

Time frame
Through 4 weeks post CRT (up to 14 weeks)

Other outcomes

1

Need to use opioids during CRT by sex

Will be assessed between arms and the corresponding 95% CIs will be provided by sex (male; female).

Time frame
Up to 7 weeks
2

Need to use opioids during CRT by race

Will be assessed between arms and the corresponding 95% CIs will be provided by race (white; other).

Time frame
Up to 7 weeks
3

Need to use opioids during CRT by ethnicity

Will be assessed between arms and the corresponding 95% CIs will be provided by ethnicity (Not Hispanic or Latino; Hispanic or Latino).

Time frame
Up to 7 weeks
4

Duration of opioid use

Will report the number of patients and descriptively summarize the duration of opioid use from the time of initiation to cessation, or 4 weeks post-CRT (acute opioid use), whichever comes first. Descriptive statistics will include the mean, standard deviation, median, interquartile range, minimum, and maximum.

Time frame
Though 4 weeks post CRT (up to 14 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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