d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC

Официальное название

A Phase I Study of d-Limonene With Concurrent Radiation and Platinum Based Chemotherapy for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Обзор

This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.

Подробное описание

Primary Objective:To determine the maximum tolerated dose (MTD) of d limonene when combined with radiation and platinum based chemotherapy in subjects with loco regionally advanced head and neck squamous cell carcinoma (HNSCC) based upon dose limiting toxicity (DLT)

Secondary Objective:

* To evaluate the feasibility and subject compliance with adjuvant administration of d limonene daily up to a maximum of 4 months after completion of chemoradiation * To correlate the level of d-limonene measured in the plasma to the dose levels(s) administered to the subject * To correlate the level of d limonene measured in the plasma to saliva flow rate and xerostomia questionnaire scores in subjects enrolled in this trial

Вмешательства

• Препарат D-Limonene Gelcaps
  Administered orally at 2 to 8 grams daily
• Лучевая терапия Intensity modulated radiotherapy (IMRT)
  Standard of Care -All patients will receive standard radiation treatment of 66 to 70 Gy given in 33 to 35 fractions (2 to 2.12 Gy/fractions) over 6.5 to 7 weeks.
• Препарат Cisplatin
  Standard of Care -Cisplatin as 100 mg/m2 IV
• Другое Xerostomia questionnaire
  Xerostomia questionnaire consists of 4 items on dryness while eating/speaking and 4 on dryness at rest. Patients rate each symptom on an 11 point ordinal Likert scale from 0 to 10, with higher scores indicating greater xerostomia

Первичные конечные точки

• Dose limiting Toxicity [Срок оценки: 9 weeks]

Вторичные конечные точки (2)

• Feasibility of adjuvant d-limonene administration [Срок оценки: 4 months]
• Xerostomia toxicity [Срок оценки: 12 months post completion of chemoradiation]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed diagnosis of advanced loco regional squamous cell carcinoma of the nasopharynx (AJCC v8 Stage II IV); oropharynx (AJCC v8 Stage I III for HPV+ cancer, excluding T1 2N0; AJCC v8 Stage III IV for Human papillomavirus (HPV) negative cancer); larynx (AJCC v8 Stage III to IV); or hypopharynx (AJCC v8 Stage III to IV), scheduled to undergo chemoradiation. Patients with squamous cell carcinoma of the head and neck from an unknown primary site with involved nodes (N1 to 3) also qualify.
• Scheduled to received definitive RT with concurrent platinum based chemotherapy at Stanford
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
• Must be able to swallow d limonene gelcaps at the time of enrollment.
• Adequate hepatic function within 2 weeks prior to registration defined as follows: Bilirubin ≤ 2 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times the upper limit of normal
• Adequate hematologic function within 2 weeks prior to registration defined as follows:

• Absolute neutrophil count (ANC): ≥ 1,500/mm3
• Platelets: ≥ 100,000/mm3
• Hemoglobin: ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable).
• Adequate renal function defined as follows:

Serum creatinine ≤ 1.5 mg/dL within 2 weeks prior to registration or creatinine clearance (CC) ≥ 50 mL/min within 2 weeks prior to registration determined by 24 hour collection or estimated by Cockcroft Gault formula:

CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dL) x (72)\] CCr female = 0.85 x (CrCl male)

• Negative serum pregnancy test within 2 weeks prior to registration and agreement to use a birth control method during the entire duration of d limonene treatment for women of childbearing potential
• Ability to understand and the willingness to sign a written informed consent document

Критерии исключения

• History of allergic reactions attributed to citrus fruits
• Pregnant or lactating

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Stanford University — Stanford

Идентификаторы

NCT: NCT04392622 · IRB-51656 · 1P01CA257907-01A1 · NCI-2021-03256

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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