Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation
RATIONALE: Acupuncture may be effective in relieving mucositis-related pain caused by chemotherapy in patients undergoing stem cell transplantation.
PURPOSE: Randomized clinical trial to study the effectiveness of acupuncture in treating mucositis-related pain caused by high-dose chemotherapy in patients who are undergoing stem cell transplantation.
Procedure: acupuncture therapy
Procedure: management of therapy complications
Procedure: pain therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing Hematopoietic Stem Cell Transplantation|
|Study Start Date:||March 2003|
- 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 groups.
- 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 intervention groups.
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 toxicity.
- Arm II: Patients undergo placebo acupuncture and receive standard pain management as in arm I.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060021
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Claude Sportes, MD||National Cancer Institute (NCI)|