High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Recruiting
Phase 3
Interventional Study
Head and Neck Squamous Cell Carcinoma
Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 228 (estimated)
- Sponsor
- Alliance for Clinical Trials in Oncology · Other
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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, wor…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.
\* Stage: I-IV
* 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 swall…
Contacts