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Managing Pain Caused by Chemotherapy in People with Myeloma or Lymphoma, OPTIMAL-HiChemo Study

Trial Status: Active

This phase III trial compares the effect of the combination of acupuncture therapy and opioids versus opioids only (usual care) for the treatment of pain in multiple myeloma and lymphoma patients who are undergoing high-dose chemotherapy. Cancer treatments can cause side effects, and one of the major side effects is pain. Treatment for severe pain usually involves opioid medications, but they may cause other side effects. Acupuncture therapy involves the insertion of very fine needles into certain points on the body and leaving them in place for about 20 minutes. Adding acupuncture therapy to the usual approach may prevent or reduce the pain caused by cancer treatments, and in turn reduce the need for opioid drugs and improve pain management in patients with multiple myeloma or lymphoma.

Inclusion Criteria

  • Pathological diagnosis of MM, HD or NHL
  • Scheduled for high dose chemotherapy for autologous hematopoietic stem cell transplantation (auto-HSCT) in the following month (30 days)
  • Not taking any opioids in the week prior to consent

Exclusion Criteria

  • Absolute neutrophil count (ANC) of < 500/ul
  • Platelet count of < 20,000/ul
  • International normalized ratio (INR) > 2.0
  • Acupuncture within two weeks prior to HiChemo (to avoid residual effects of acupuncture)
  • Unable to provide informed consent

New Jersey

Hackensack
Hackensack University Medical Center
Status: IN_REVIEW
Contact: Michele L. Donato
Phone: 551-996-8297

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Gary E. Deng
Phone: 646-888-0841

PRIMARY OBJECTIVES:

I. To determine the comparative effectiveness of acupuncture and opioids (ACU) versus opioids only (OPI) in reducing opioid use during and after high-dose chemotherapy (HiChemo) among patients who do not use opioids at baseline before HiChemo and in reducing their symptom burden during HiChemo.

II. To determine the short-term (day 7) and long-term (day 90) effects of ACU compared to OPI on patient-reported pain, opioid side effects (e.g. drowsiness, constipation, nausea), and quality of life among the above study population.

EXPLORATORY OBJECTIVES:

I. Explore whether the effect of ACU treatment on day 90 opioid use is mediated by its effect on day 7 opioid use.

II. Explore whether sex, race, ethnicity, gender, primary cancer diagnosis (multiple myeloma [MM] versus Hodgkin disease [HD] versus non-Hodgkin lymphoma [NHL]), Opioid Risk Tool (ORT), Acupuncture Expectancy Scale (AES) score, or concurrent use of other medications with analgesic effects influence response to interventions in this population (i.e., heterogeneity of treatment effect, HTE).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning the day after the first dose of HiChemo, patients undergo acupuncture therapy over 20 minutes once daily (QD) on days 0-15. Patients also receive usual care for opioid administration.

ARM II: Patients receive usual care for opioid administration.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Gary E. Deng

  • Primary ID 20-264
  • Secondary IDs NCI-2020-05216
  • Clinicaltrials.gov ID NCT04459416