Acupuncture for the Treatment of Cancer Related Fatigue

Phase 2

Terminated

• Conditions: Fatigue
• Interventions: Other: Acupuncture

• Registration Number: NCT01572168
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

Cancer-related fatigue occurs in both adult and pediatric patients undergoing chemotherapy and/or radiation. Recently, methods to measure fatigue have improved - however, no non-medication interventions have been studied. Ameliorating fatigue may result in an improved quality of life for patients. Acupuncture is a safe and well-tolerated procedure and has been used for many indications in pediatric patients. Adult studies have suggested improvement in cancer-related fatigue after acupuncture in adults. In this trial, we propose using acupuncture for the treatment in cancer-related fatigue in children and adolescents with central nervous system tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Patients who are ≥ 8 year of age and ≤ 21 years of age who are undergoing chemotherapy and/or radiation therapy for the treatment of any primary or recurrent central nervous system tumor (regardless of diagnosis or disease stage, whether it is malignant or benign, and in any location) at Children's Memorial Hospital.
• Patients who recently completed therapy (within 60 days of enrollment) will also be eligible. Patients must have a minimum baseline fatigue score of 15 on the pedsFACIT-F scale (Range 0-44). This is not a standard assessment for required clinical care and will only be administered by a research assistant to any patient after consent has been obtained. The assessment will be done during a routine clinic visit.
• For patients receiving cytotoxic chemotherapy with a history of myelosuppression or radiation, a hemoglobin concentration of >8 g/dL measured within 10 days of enrollment and a platelet count of > 30,000 within 5 days of enrollment is required.
• Patients must also be able to read and understand English and read a computer screen.
• Patients with no known contraindications to acupuncture therapy.
• Patients who are able to attend all scheduled visits for acupuncture.
• Patients must have a Karnofsky Performance Score of ≥ 50% or a Lansky Performance Score of ≥ 50.
• Patients who have provided informed consent for the research study (parental consent for patients < 18 years of age). Patients between 12 years and 18 years of age must provide assent in additional to parental consents.

Exclusion Criteria

• Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue.
• Patients who have received acupuncture in the previous six weeks.
• Patients with a life expectancy < 3 months.
• Patients who are pregnant or lactating.
• Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Eight sessions of weekly acupuncture

Primary Outcome Measures

Name	Time	Method
cancer-related fatigue	Participants will be on-study for up to 14 weeks. . No follow-up will be required after the completion of the study.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States