Clinical Trial: Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing Hematopoietic Stem Cell Transplantation

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

  • 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
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome:

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: May 6, 2003
    Date Started: March 2003
    Date Completion:
    Last Updated: April 29, 2015
    Last Verified: April 2004