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NCT03423264
PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
Phase 2 trial testing Gabapentin in Oropharyngeal Cancer. Withdrawn.
8 November 2022
Quick facts
| Lead sponsor | University of Chicago |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Start date | 22 January 2018 |
| Primary completion | 8 November 2022 |
| Estimated completion | 8 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gabapentin (Gabapentin) — full drug profile →
Conditions studied
- Oropharyngeal Cancer — all drugs for Oropharyngeal Cancer →
- HPV-Related Squamous Cell Carcinoma — all drugs for HPV-Related Squamous Cell Carcinoma →
Sponsor
University of Chicago
Who can join
18 and older, any sex, with Oropharyngeal Cancer or HPV-Related Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03423264
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gabapentin
Trials testing the same drug.
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- NCT04613024 — Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty · EARLY_PHASE1 · withdrawn
- NCT07389551 — Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic · NA · completed
- NCT06992427 — High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Che · Phase 3 · recruiting
Other recruiting trials for Oropharyngeal Cancer
Currently open trials in the same condition.
- NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
- NCT06446713 — PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer · Phase 1 · recruiting
- NCT06747390 — Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery · Phase 1 · recruiting
- NCT05363709 — BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients · Phase 2 · active not recruiting
- NCT05862792 — Liposomal Bupivacaine and Transoral Robotic Surgery · recruiting
Other University of Chicago trials
Trials by the same sponsor.
- NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
- NCT07354100 — Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy · Phase 1, PHASE2 · not yet recruiting
- NCT06446661 — Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia · NA · not yet recruiting
- NCT07179315 — A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Tr · Phase 2 · not yet recruiting
- NCT07126561 — Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03423264 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Chicago
- Last refreshed: 31 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03423264.
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