Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out what effects (good and bad) SAMITAL (Vaccinium myrtillus extract/Macleaya cordata alkaloids/Echinacea angustifolia extract granules) has on the management of mucositis (inflammation and ulceration that occurs in the mouth) brought on by chemotherapy and radiation therapy for squamous cell carcinoma of the head and neck

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

• Patients with no distant metastatic disease

• Have histologically proven diagnosis of squamous cell carcinoma (stage III - IV) of the paranasal sinuses, nasopharynx, larynx, hypopharynx, oral cavity and/or oropharynx; treated with definitive concurrent chemoradiotherapy; OR histologically proven diagnosis of squamous cell carcinoma of the paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx with finding of need for concurrent chemoradiotherapy (extracapsular extension, positive surgical margin, more than one lymph node positive, stage III - IV disease, perineural invasion, vascular tumor embolus); other rare histologies which are treated as per the guidelines of this protocol may be allowed with approval of the medical monitor

• Concurrent monochemotherapy with cisplatin

• Radiation therapy to 70 Gray (Gy) to gross tumor in 2 Gy per fraction over 7 weeks using intensity modulated radiation therapy (IMRT) techniques for patients with intact tumors, and 60 Gy - 66 Gy in 2 Gy per fraction using IMRT for post-operative patients

• Induction chemotherapy (with up to 3 cycles of docetaxel and cisplatin based regimens) is allowed

• Ability to swallow and retain oral medication

• Leukocytes >= 3,000/uL

• Absolute neutrophil count >= 1,500/uL

• Platelets >= 100,000/uL

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit normal (ULN)

• Calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault equation)

• Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Contraindication to full course chemoradiotherapy

• ECOG performance status >= 3

• Presence of distant metastatic disease

• Surgery with significant defect or flap in the oral cavity

• Poor dentition, ill-fitting dental appliances, obturators or any kind of resection prosthesis (can be enrolled if this can be corrected by a dentist prior to start of radiation therapy)

• Presence of other medical conditions causing mucositis (e.g., rheumatologic, severe gastroesophageal reflux, etc. at the discretion of the physician)

• Previous radiotherapy on head and neck district involving mucosa of oral cavity and/or oropharynx

• Use of chronic immunosuppressive drugs

• Brachytherapy or interstitial implantation treatment

• Other medical conditions that could make the patient not able to comply with the treatment

• Requirement of chronic steroid therapy (except when given for laryngeal edema)

• Pregnant or nursing female patients

• Unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

• Received an investigational agent within 30 days prior to enrollment