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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma, Hodgkin Disease, Non-Hodgkin Lymphoma

Intervention / Treatment
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* Other: Acupuncture
* Drug: opioid
* Other: Assessments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual Care plus Acupuncture<br>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. | Other: Acupuncture<br>* 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.<br>Drug: opioid<br>* All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.<br>Other: Assessments<br>* 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.<br>|
| Active Comparator: Usual Care<br>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. | Drug: opioid<br>* All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.<br>Other: Assessments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients using opioids at a given time | 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 | up to 90 days | 
| symptom burden | 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. | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Acupuncture, 20-264