Schedule of enrolment, treatments and assessments
Enrolment and baseline | CIPN Screening | Randomisation | Intervention period | Follow-up period week 8 | Follow-up period week 24 | |
Time point | −t1 | Weekly at infusion (0) | After CIPN symptom onset (0) | Weekly for 10 weeks (t1 – t10) | t10+8 w (± 2 weeks) | t10+24 w (± 2 weeks) |
Enrolment: | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Interventions: | ||||||
Electroacupuncture | X | |||||
Sham-electroacupuncture | X | |||||
Assessments: | ||||||
ESAS 17 | X | X | ||||
EORTC QLQ-CIPN20 | X | X | X | X | ||
Patient feedback form | X (t10) | |||||
AES | X | X (t5 + t10) | ||||
Concomitant CIPN treatments | X | X | X | X |
AES, Acupuncture Expectancy Scale; CIPN, chemotherapy-induced peripheral neuropathy; EA, electroacupuncture; EORTC QLQ-CIPN20, European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy 20; ESAS 17, Edmonton Symptom Assessment Scale 17; X, required.