[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ii-head-and-neck-cutaneous-squamous-cell-carcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ii-head-and-neck-cutaneous-squamous-cell-carcinoma-ajcc-v8":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100556989","phase-2-testing-the-addition-of-the-drug-bmx-001-a-radioprotector-or-a-placebo-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-100556989",false,"NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.","ALL","18 Years",{"count":19,"type":20},98,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stomatitis","RECRUITING","2026-06-22",{"date":70,"type":71},"2026-06-25","ACTUAL",{"date":73,"type":71},"2025-06-23",{"date":75,"type":20},"2027-01-01",{"name":77,"class":78},"NRG Oncology","OTHER",153,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100592361","phase-3-high-dose-prophylactic-gabapentin-hope-vs-placebo-to-prevent-opioid-use-for-oral-mucositis-pain-during-concurrent-chemoradiation-for-head-and-neck-cancer-100592361","NCT06992427","High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer","High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial","HOPE","Inclusion Criteria:\n\n* Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.\n\n  \\* Stage: I-IV\n* No prior treatment for head and neck cancer\n* Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks \\[q 3 week\\])\n* Able to swallow capsules whole\n* No known hypersensitivity to gabapentin or its ingredients\n* No patients on dialysis or with transplanted organs\n* No prior surgery or radiation for head and neck cancer and\u002For are being treated for recurrent head and neck cancer. Patients with a history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible. Concurrent cancer therapy for other cancers is not allowed\n* No planned surgery or chemotherapy or immunotherapy following 7 weeks of standard chemoradiation treatment\n* No known brain metastases\n* No nonprescribed use of any opioids (including heroin) within 6 months prior to registration\n* No prescribed medications for chronic and\u002For long-term pain and\u002For neuropathy, including patients under treatment of a pain specialist or substance abuse programs. Acute post-biopsy medications are allowed if the patient has discontinued them 3 days prior to study registration\n* No current treatment with mefloquine\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Creatinine ≤ 1.5 x upper limit of normal (ULN)\n* Not pregnant and not nursing, because this study involves both radiation and chemotherapy. In addition, the genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done \\\u003C 7 days prior to registration is required. Women must agree to using contraception for the duration of receiving study drugs and for 6 months after completing chemoradiation\n* Not taking medications for a psychotic psychiatric illness\n* No existing diagnosis of sleep apnea\n* No acute narrow-angle glaucoma\n* No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* No investigational agent within 30 days prior to registration\n* No enrollment on other studies of systemic pain control agents\n* Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish\n* Patients with impaired decision making are not eligible for study\n\nExclusion Criteria:\n\n\\-",{"count":89,"type":20},228,[91],"PHASE3","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",[29,39,45,51,94],"Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","2026-05-07",{"date":97,"type":71},"2026-05-11",{"date":99,"type":71},"2025-06-05",{"date":101,"type":20},"2031-04-15",{"name":103,"class":78},"Alliance for Clinical Trials in Oncology",200]