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

Phase 3

Active, not recruiting

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Usual Care plus Acupuncture	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.
Usual Care plus Acupuncture	opioid	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.
Usual Care plus Acupuncture	Assessments	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.
Usual Care	Assessments	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.
Usual Care	opioid	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.

Primary Outcome Measures

Name	Time	Method
the Number of Patients Using Opioids at a Given Time	at day 90	at a given time divided by the total number of patients randomized to that group at Day 90) by review of medication records and urine drug test
Symptom Burden	At Day 90	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. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale

Secondary Outcome Measures

Name	Time	Method

Locations (3): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Fred Hutchinson Cancer Research Center
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Seattle, Washington, United States
Seattle Cancel Care Alliance (Data Collection Only)
🇺🇸
Seattle, Washington, United States