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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060021
• Other study ID #: CDR0000299048
• Secondary ID: NCI-03-C-0125
• Status: Completed
• Phase: N/A
• First received: May 6, 2003
• Last updated: April 29, 2015
• Start date: March 2003

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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 receive standard pain management as in arm I.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Must be undergoing hematopoietic stem cell transplantation (HSCT) through one of the following means:

• Concurrent enrollment on a HSCT protocol with the Experimental Transplantation & Immunology Branch (ETIB) at the NCI Center for Clinical Research*

• Receiving HSCT as a compassionate exemption following the clinical guidelines of an ETIB protocol*

• Directly observed oral or pharyngeal mucositis and/or suspected esophageal mucositis after high-dose chemotherapy

• No pain unrelated to mucositis requiring use of potent analgesics prior to initiation of high-dose chemotherapy NOTE: *Protocol must be known to generate more than 50% incidence of high-dose chemotherapy-induced mucositis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No history of bleeding disorders

Hepatic

• PT and PTT normal

Renal

• Not specified

Other

• No history or evidence of drug addiction or drug-seeking behavior

• No skin infection at the sites of acupuncture points

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent anticoagulant therapy

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• acupuncture therapy

• management of therapy complications

• pain therapy

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,