Track topics on Twitter Track topics that are important to you
RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.
- Determine whether doxepin hydrochloride mouth rinse, compared to placebo, is effective in reducing oral mucositis-related pain in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy.
- Assess the adverse event profile of these regimens, using a patient-reported questionnaire at 5, 15, 30, 60, 120, and 240 minutes, in these patients.
- Compare the incidence of using alternative analgesics 4 hours before and in between these regimens in these patients.
- Assess patient preference for continuing therapy with oral doxepin hydrochloride after initial test rinse or after optional cross-over phase.
- Assess pain reduction and other adverse event profile in patients who cross-over to the optional blinded phase using the same patient-reported questionnaire.
- Assess pain reduction and other adverse event profile in patients who continue to receive optional oral doxepin hydrochloride.
OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm II on day 2.
- Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm I on day 2.
NOTE: * Patients are instructed to avoid taking medications for mucositis pain 60 minutes before and after study medication.
After completing study therapy, patients have the option to receive doxepin hydrochloride oral rinse every 4 hours as needed during radiotherapy.
Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes after study medication. Patients who choose to continue doxepin hydrochloride oral rinse also complete weekly questionnaires.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
Head and Neck Cancer
doxepin hydrochloride, placebo
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:00:46-0400
This pilot randomized clinical trial studies the effects, good and/or bad, of taking doxepin hydrochloride compared to placebo (inactive drug) in treating esophageal pain in patients with ...
This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving ...
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone may be effective in preventing head and ne...
Through this study, we hope to learn more about the mechanisms, which may contribute to development and progression of head and neck cancer. The long-term goal of this study will be to de...
The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient
Information on re-irradiation (re-RT) for recurrent and second primary head and neck cancer is limited. Herein, a description of our long-term experience of re-RT for previously irradiated head and ne...
Head and neck cancers comprise 4% of the cancer burden in the United States each year. Many types of head and neck cancers present as an asymptomatic, nontender neck mass or nonspecific symptoms, such...
Patients with head and neck squamous cell cancer (HNSCC) are often uninsured or underinsured at the time of their diagnosis. This access to care has been shown to influence treatment decisions and sur...
Primary care patients with a suspected head and neck cancer are referred through the urgent suspicion of cancer referral pathway. Rates of cancer detection through this pathway are low. Evidence surro...
Patients with head and neck cancer (HNC) experience increased risk of depression and compromised quality of life. Identifying patients with HNC at risk of depression can help establish targeted interv...
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.
A form of RHABDOMYOSARCOMA arising primarily in the head and neck, especially the orbit, of children below the age of 10. The cells are smaller than those of other rhabdomyosarcomas and are of two basic cell types: spindle cells and round cells. This cancer is highly sensitive to chemotherapy and has a high cure rate with multi-modality therapy. (From Holland et al., Cancer Medicine, 3d ed, p2188)
A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.
Large veins on either side of the root of the neck formed by the junction of the internal jugular and subclavian veins. They drain blood from the head, neck, and upper extremities, and unite to form the superior vena cava.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...