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

NCT ID: NCT00060021

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31

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 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Interventions

acupuncture therapy

Intervention Type: PROCEDURE

management of therapy complications

Intervention Type: PROCEDURE

pain therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Claude Sportes, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-03-C-0125

Identifier Type: -

Identifier Source: secondary_id

CDR0000299048

Identifier Type: -

Identifier Source: org_study_id