A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing Hematopoietic Stem Cell Transplantation
- Compare the efficacy of acupuncture vs placebo acupuncture in alleviating
mucositis-related pain secondary to high-dose chemotherapy, as assessed by total
cumulative dose of opioids used and subjective pain scores, in patients undergoing
hematopoietic stem cell transplantation.
- Compare the overall number of patients requiring opioid therapy in these 2 intervention
- Compare the nausea and vomiting scores of patients in these 2 intervention groups.
- Compare the sedation score of patients in these 2 intervention groups.
- Compare the use of other psychotropic medications (e.g., anxiolytics or hypnotics) in
patients in these 2 intervention groups.
- Compare the need for total parenteral nutrition (TPN) and the number of days on TPN
experienced by patients in these 2 intervention groups.
- Compare pruritus and the need for symptomatic treatment in patients in these 2
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to 9-phenylthiocarbamide/6-n-propylthiouracil (PROP) tasting ability
(super-tasters vs non-super-tasters). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning immediately after the development of mucositis pain, patients undergo
acupuncture over 30 minutes once daily. Patients also receive standard pain management.
Treatment continues until pain is completely resolved in the absence of unacceptable
- Arm II: Patients undergo placebo acupuncture and receive standard pain management as in
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 3 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Claude Sportes, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|