Neoplasms

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Carcinoma, Squamous Cell

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Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

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Neoplasms, Squamous Cell

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Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality-of-Life Assessment

Questionnaire Administration

Venlafaxine

Venlafaxine Hydrochloride Extended Release

Anurag Singh

This trial studies how well gabapentin, methadone, and oxycodone with or without venlafaxine hydrochloride work in managing pain in participants with stage II-IV squamous cell head and neck cancer undergoing chemoradiation therapy. Gabapentin may reduce the need for these pain medications if given at the start of radiation therapy. Methadone and oxycodone may help relieve pain caused by cancer. Venlafaxine hydrochloride may prevent or improve pain caused by cancer. It is now yet known whether giving gabapentin, methadone, and oxycodone with venlafaxine hydrochloride will work better in managing pain in participants with squamous cell head and neck cancer undergoing chemoradiation therapy.

PRIMARY OBJECTIVES:

I. To assess the pain-reduction effects of adding venlafaxine to a regimen of gabapentin and methadone to control pain during and after chemoradiation.

SECONDARY OBJECTIVES:

I. To assess the effect of venlafaxine hydrochloride (venlafaxine) of the rate of toxicities possibly or probably related to the pain control regimen.

TERTIARY OBJECTIVES:

I. The effect of venlafaxine on other quality of life scores, patient nutrition, hydration status, and opioid requirements during and after chemoradiotherapy (CRT).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive gabapentin orally (PO) daily or 3 times a day (TID). Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

ARM II: Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO twice daily (BID) or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 4 weeks, 3, 6, 9, and 12 months, and then every 6 months for up to 24 months.

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy

A Randomized, Open-Label Study to Assess the Pain, Toxicity, and Quality of Life Effects of Adding Venlafaxine to the Pain Management Regimen for Patients Treated With Chemoradiation for Head and Neck Cancer

Change in Pain Scale score is measured repeatedly during the 7-week radiation treatment process, and periodically for as long as the patient receives pain management treatment, up to 24 months after enrollment. The magnitude, direction and 95% confidence interval for the adjusted interaction term estimate will be used to describe the effect venlafaxine in improving the pain management regimen.

Toxicities will be tabulated by treatment arm using the maximum grade observed by participant. Possible differences by treatment will be described using odds ratio and 95% confidence interval estimates derived use Mantel?Haenszel methods to account for laterality of the radiation treatment.

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy	NCT03574792	Stage III Cutan... Stage IV Cutane...	Gabapentin Methadone Oxycodone Quality-of-Life... Questionnaire A... Venlafaxine Venlafaxine Hyd...	18 Years -	Roswell Park Cancer Institute
Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy	NCT03574792	Stage III Cutan... Stage IV Cutane...	Gabapentin Methadone Oxycodone Quality-of-Life... Questionnaire A... Venlafaxine Venlafaxine Hyd...	18 Years -	Roswell Park Cancer Institute

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