Methadone to Treat Painful Chemotherapy Induced Peripheral Neuropathy

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Chemotherapy-induced Peripheral Neuropathy
Interventions
DRUG

methadone

"The treatment arm will take methadone 2 mg PO q8h and a placebo called placeboD PO qdaily. PlaceboD and duloxetine will be placed in capsules to be virtually indistinguishable.~Participants will be followed (televisit or in-person) by assessors every week; this will take approximately 15 minutes. This includes review of questionnaire(s), adverse events (and any potential management), and recommendations on dose titration. To maintain blinding and ensure standardization across assessors, titration protocols will be provided. If pain is not controlled, the assessors will instruct the participant to increase their methadone/placeboM drug by 1 capsule PO q8h and their duloxetine/placeboD drug to 2 capsules PO qdaily (the study maximum). If there are poorly tolerated adverse events the dose will be reduced to the previously tolerated dose, and then the following week they may attempt to titrate up again per the above protocol."

DRUG

duloxetine

"The control arm will receive duloxetine 30 mg PO qdaily, and a placebo called placeboM PO q8h. PlaceboM and methadone will be placed in capsules to be virtually indistinguishable.~Participants will be followed (televisit or in-person) by assessors every week; this will take approximately 15 minutes. This includes review of questionnaire(s), adverse events (and any potential management), and recommendations on dose titration. To maintain blinding and ensure standardization across assessors, titration protocols will be provided. If pain is not controlled, the assessors will instruct the participant to increase their methadone/placeboM drug by 1 capsule PO q8h and their duloxetine/placeboD drug to 2 capsules PO qdaily (the study maximum). If there are poorly tolerated adverse events the dose will be reduced to the previously tolerated dose, and then the following week they may attempt to titrate up again per the above protocol."

Trial Locations (4)

Unknown

NOT_YET_RECRUITING

Nanaimo Regional Hospital, Nanaimo

RECRUITING

BC Cancer Surrey, Surrey

NOT_YET_RECRUITING

BC Cancer Victoria, Victoria

V5Z 4E6

NOT_YET_RECRUITING

BC Cancer Vancouver, Vancouver

All Listed Sponsors
collaborator

British Columbia Cancer Agency

OTHER

lead

University of British Columbia

OTHER