Patients received two capsules of placebos per day during 3 years. Outcome Measures. Primary Outcome Measures : Second primary cancers [ Time Frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, ].
Secondary Outcome Measures : Acute and late side-effects of radiation therapy [ Time Frame: During radiation therapy RT , at the end of RT, one month after RT, six months after RT and 1 year after RT ] Quality of life [ Time Frame: Baseline, at the end of radiation therapy RT , 1, 6,12,24 and 36 months after RT ] Recurrence [ Time Frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, ] Cancer free survival [ Time Frame: Immediately and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, ] Without recurrence and without second primary cancer.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Histologically documented stage I or II head and neck cancer Exclusion Criteria: Karnofsky performance score of less than 60 Multiple primary head and neck cancer History of cancer Severe cardiovascular disease Inadequate renal, hepatic or hematologic function Anticoagulant therapy Pregnancy Average daily supplement intake of beta-carotene or vitamin E in the preceding year greater than 6.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Randomized trial of antioxidant vitamins to prevent acute adverse effects of radiation therapy in head and neck cancer patients.
J Clin Oncol. Epub Jul A randomized trial of antioxidant vitamins to prevent second primary cancers in head and neck cancer patients. J Natl Cancer Inst. Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients.
Int J Cancer. Acute adverse effects of radiation therapy and local recurrence in relation to dietary and plasma beta carotene and alpha tocopherol in head and neck cancer patients. Nutr Cancer. Prognostic significance of cyclooxygenase-2 overexpression in glottic cancer. The participants will be randomized valproic acid : placebo. The primary outcome is to document histone acetylation and DNA methyltransferase expression DNMT in saliva collected from participants when comparing valproic acid arm with placebo arm.
Detailed Description:. Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Head and neck squamous cell carcinoma. Drug Information available for: Valproic acid Valproate sodium Divalproex sodium. FDA Resources. Arms and Interventions. Half of the participants will receive valproic acid orally for three months. Placebo will be orally administered in a total dose of three capsules per day every 8 hours , for three months.
The other half of the participants will receive placebo for three months. Outcome Measures. Primary Outcome Measures : Changes in protein or histone acetylation [ Time Frame: Three months after study enrollment ] Saliva samples will be collected in baseline and three months after study enrolment. Saliva samples will be collected in baseline and three months after study enrolment.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Patients that signed the formal consent; Previous history of head and neck squamous cell carcinoma with no more than three years of follow-up; History of squamous cell carcinoma in the following sub-sites: oral cavity, oropharynx, larynx and hypopharynx; Absence of active malignant disease HNSCC with at least three months of follow-up without signs of residual disease, recurrence or second primary invasive tumors ; Normal liver, hematologic and renal function.
Former users were defined as patients who had quit smoking at least one year prior to diagnosis and smoked more than cigarettes in their lifetime. Exclusion Criteria: Any active malignancy; History of invasive malignancies other than HNSCC diagnosed within the last 2 years controlled non-melanoma skin cancer are an exception ; History of hepatitis B, hepatitis C, HIV, chronic liver disease or chronic pancreatic disease; Any comorbid medical or psychiatric disorder that it is not well controlled; Patients under immunosuppression or under systemic corticosteroid therapy to treat any active autoimmune disease; Patients that still have documented toxicities greater than grade 1 CTCEA NCI v4.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Cancer Prev Res Phila. Epub Jan Valproic acid defines a novel class of HDAC inhibitors inducing differentiation of transformed cells.
EMBO J. Valproic acid: growth inhibition of head and neck cancer by induction of terminal differentiation and senescence. Journal Information. Explore Articles. Open Access. For Visitors. Related Articles. Content Access Key Password. Login to Download Close. Conclusion: With evidence that retinoid treatment adversely affects survival of lung cancer and with this drug not significantly decreasing the incidence of second primary tumors of head and neck squamous cell carcinoma, the use of this drug in head and neck cancer patients for second cancer prophylaxis is not indicated.
Abstract Objective: To determine whether isotretinoin or cis-retinoic acid decreases the risk of second primary cancers in patients previously treated for cure of head and neck squamous cell carcinoma.
Substances Retinoids.
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