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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 3

Conditions: Multiple Myeloma; Hodgkin Disease; Non-Hodgkin Lymphoma

Treatments: Drug: opioid; Other: Acupuncture; Other: Assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT04459416

20-264

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

Usual Care plus Acupuncture

Experimental group

Description:

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.

Treatment:

Other: Assessments

Other: Acupuncture

Drug: opioid

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Assessments

Drug: opioid