Managing Pain Caused by Chemotherapy in People with Myeloma or Lymphoma, OPTIMAL-HiChemo Study
- 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
- 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
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.
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
Memorial Sloan Kettering Cancer Center
Gary E. Deng
- Primary ID 20-264
- Secondary IDs NCI-2020-05216
- Clinicaltrials.gov ID NCT04459416