Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Pain

Head and Neck Neoplasms

Stomatitis

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Mouth Diseases

Stomatognathic Diseases

Quality of Life

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Antitussive Agents

Respiratory System Agents

Anticonvulsants

Psychotropic Drugs

Anti-Obesity Agents

Vasoconstrictor Agents

Oxycodone

Methadone

Gabapentin

Analgesics, Opioid

Narcotics

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy.

All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy.

All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Methadone Hydrochloride

Oxycodone Hydrochloride

Quality-of-Life Assessment

Questionnaire Administration

Anurag Singh

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 quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.

PRIMARY OBJECTIVES:

I. Collect preliminary data on the safety and efficacy of two analgesic regimens that can be used to design larger studies for comparing such regimens.

SECONDARY OBJECTIVES:

I. Examine effects of the treatment regimens on pain control, oral mucositis, and quality-of-life ratings scores during and after chemoradiation therapy (CRT).

TERTIARY OBJECTIVES:

I. To assess treatment regimen effect on patient nutrition and hydration status during and after CRT (weight loss, vitals, oral \[PO\] tolerance, etc.).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive gabapentin PO thrice daily (TID) for up to 7 weeks during radiotherapy.

ARM II: Patients receive gabapentin PO TID, methadone hydrochloride PO twice daily (BID), and oxycodone hydrochloride PO every 8 hours (Q8H) as needed (PRN) for up to 7 weeks during radiotherapy.

All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

After completion of study, patients are followed up at 30 days, and at 3, 6, 9, and 12 months. Patients requiring prolonged analgesic therapy may be followed up every 6 months for 24 months.

Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

Analysis of Analgesia Regimens During Concurrent Chemoradiation for Head and Neck Cancer: A Pilot Study

Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Will be graded and recorded. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate. The frequency of toxicities will be tabulated by grade by treatment arm.

Each patient requiring rescue medication for breakthrough or refractory pain will be counted as a failure for that specific regimen. At the end of the trial, number of failures will be compared between the two treatment arms using Fisher's exact test. Total amount of opioid intake mean will be compared using a t-test between the two arms. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate

The total score of the OMDQ questionnaire will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

The total score of the EORTC questionnaires will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Roswell Park Cancer Institute

Nervous System Diseases

Rare Diseases

Parasomnias

Nausea

Vomiting

Cancer Pain

Sleep Wake Disorders

Signs and Symptoms, Digestive

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Chronic Graft Versus Host Disease

Level 1: 1 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA\*\* per day)

Level 2: 2 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 3: 3 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 1: 2 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 2: 3 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 3: 4 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 1: 1 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA\*\* per day)

Level 2: 2 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 3: 3mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

OR

Level 1: 2 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 2: 3 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

Level 3: 4 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

methadone hydrochloride

questionnaire administration

management of therapy complications

Bruno Gagnon, MD, MSC

Ray Viola

RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer pain.

OBJECTIVES:

Primary

* To determine the optimum starting dose (defined as the dose that does not require modification within the first 4 days of treatment for lack of efficacy or the occurrence of adverse events) of methadone hydrochloride as a first-line opioid treatment in patients with chronic neuropathic cancer pain.

Secondary

* To assess the number and timing of breakthrough analgesic usage.
* To assess the number of episodes of breakthrough pain.
* To assess the total daily dose of methadone hydrochloride.
* To assess the average pain score.
* To determine the safety and adverse event profile of methadone hydrochloride as a first-line opioid in the treatment of chronic neuropathic cancer pain.
* To assess the frequency and severity of sleep disturbance associated with the use of methadone hydrochloride.
* To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone hydrochloride vs morphine.

OUTLINE: This is a multicenter study. Patients are assigned to a group according to their average daily dosage of morphine-equivalent for the 3 full days prior to study entry (≤ 45 mg/day OR \> 45 but ≤ 75 mg/day).

Patients receive oral methadone hydrochloride at various doses every 8 hours. Patients also may receive breakthrough oral methadone hydrochloride every 2 hours, as needed, for up to 6 breakthrough analgesics per day. Treatment continues for up to 35 days. Treatment stops if the patient has well-controlled pain or experiences intolerable side effects.

Patients complete the Short-Form McGill Pain Questionnaire at baseline. Patients rate their pain according to questions from the Brief Pain Inventory on a scale of 0 (no pain) to 10 (worst pain imaginable) to best describe pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on average, and pain right now; record the number and timing of breakthrough analgesic usage, the number of episodes of breakthrough pain, and the total daily dose of methadone hydrochloride; and complete nausea and sleep assessments once daily on days 1-14.

After completion of study treatment, patients are followed at 4, 6-7, and 28 days.

Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain

A Phase I Study to Determine the Dose of Methadone as a First Line Agent in the Treatment of Chronic Neuropathic Cancer Pain

NCIC Clinical Trials Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation	NCT02531906	Head and Neck S... Pain Stomatitis	Gabapentin Methadone Hydro... Oxycodone Hydro... Quality-of-Life... Questionnaire A...	18 Years -	Roswell Park Cancer Institute
Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation	NCT02531906	Head and Neck S... Pain Stomatitis	Gabapentin Methadone Hydro... Oxycodone Hydro... Quality-of-Life... Questionnaire A...	18 Years -	Roswell Park Cancer Institute
Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain	NCT00930332	Nausea and Vomi... Pain Sleep Disorders Unspecified Adu...	methadone hydro... questionnaire a... management of t...	18 Years -	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for methadone hydrochloride