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

NCT04459416 | Active Not Recruiting Phase 3 Results

• 1 other identifier: 20-264
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma; Hodgkin Disease; Non-Hodgkin Lymphoma

Keywords

Pain management; Acupuncture; 20-264

Outcome Measures

Primary Outcomes (5)

• 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) by review of medication records and urine drug test

  at day 7

• 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 90) by review of medication records and urine drug test

  at day 90

• 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. 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

  At baseline

• 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. 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

  At Day 7

• 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. 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

  At Day 90

Study Arms (2)

Usual Care plus Acupuncture

EXPERIMENTAL

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; Drug: opioid; Other: Assessments

Usual Care

ACTIVE COMPARATOR

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; Other: Assessments

Interventions

Acupuncture OTHER

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.

Usual Care plus Acupuncture

opioid DRUG

All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.

Usual Care; Usual Care plus Acupuncture

Assessments OTHER

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.

Usual Care; Usual Care plus Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Hackensack Meridian Health: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Seattle Cancel Care Alliance (Data Collection Only)

Seattle, Washington, 98109, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Agnosia

Interventions

Acupuncture Therapy; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr. Gary Deng, MD, PhD
• Organization: Memorial Sloan Kettering Cancer Center

dengg@MSKCC.ORG

646-608-8556

Study Officials

• Jun Mao, MD, MSCE

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: June 30, 2020
• Primary Completion: July 2, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 20, 2025
• Results First Posted: December 4, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (3)