Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma

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

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.

This is a multicenter, two-arm randomized controlled trial. Randomization will be stratified by study site, primary cancer diagnosis (MM versus HD versus NHL) and transplantation setting (inpatient versus outpatient) to ensure these characteristics are comparably distributed between the two study arms.

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. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief.

Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care.

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.

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

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.

at a given time divided by the total number of patients randomized to that group at Day 7 and Day 90) by review of medication records and urine drug test

measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint.

Inclusion Criteria: age 18 or older pathological diagnosis of MM, HD or NHL scheduled for high dose chemotherapy for auto-HSCT in the following month (30 days) not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed) Exclusion Criteria: absolute neutrophil count (ANC) of <500/μl, platelet count of <20,000/ μl or INR >2.0 acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture) unable to provide informed consent

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.