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NCT04459416 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04459416
Other study ID # 20-264
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 30, 2020
Est. completion date June 2025

Study information
Verified date August 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Acupuncture
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.
Drug:
• opioid
All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.
Other:
• Assessments
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.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Seattle Cancel Care Alliance (Data Collection Only) Seattle Washington

Sponsors (3)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Hackensack Meridian Health, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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