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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04459416

Collaborator

Patient-Centered Outcomes Research Institute (Other), Hackensack Meridian Health (Other)

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

100

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Hodgkin Disease Non-Hodgkin Lymphoma	Other: Acupuncture Drug: opioid Other: Assessments	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Usual Care plus Acupuncture 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 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.
Active Comparator: Usual Care 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 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.

Arm

Intervention/Treatment

Experimental: Usual Care plus Acupuncture

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

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.

Active Comparator: Usual Care

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

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

Outcome Measures

Primary Outcome Measures

the number of patients using opioids at a given time [up to 90 days]
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
symptom burden [up to 90 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
2	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
3	Seattle Cancel Care Alliance (Data Collection Only)	Seattle	Washington	United States	98109