CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 299 enrolled
Drug / intervention
opioid +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04459416
NCT04459416Phase 3Active

Opioid-Sparing Pain Treatment In Myeloma And Lymphoma Patients Undergoing High-Dose Chemotherapy (OPTIMAL-HiChemo): Randomized Controlled Trial

Memorial Sloan Kettering Cancer Center·interventional·Posted Jul 7, 2020·Updated Oct 20, 2025

In Brief

A Phase 3 clinical trial evaluating Acupuncture, opioid, and 1 other intervention for Multiple Myeloma and 2 related conditions. Active but no longer recruiting, targeting 299 participants across 3 sites.

Detailed Summary

The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3ActiveOverdue
202120222023202420252026
First PostedJul 7, 2020
Enrollment StartJun 30, 2020
Primary CompletionJul 2, 2024
Study CompletionJun 1, 2026
TodayJul 1, 2026
Enrollment to primary: 4.0 yearsPosted 6.0 years ago

Interventions

Acupunctureother

Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice.

opioiddrug

All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.

Assessmentsother

Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.