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Acupuncture for the Treatment of Cancer Related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572168
Recruitment Status : Terminated (slow accrual)
First Posted : April 6, 2012
Last Update Posted : February 5, 2016
Information provided by (Responsible Party):
Rishi Lulla, 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.

Condition or disease Intervention/treatment Phase
Fatigue Other: Acupuncture Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Study of Acupuncture for the Treatment of Cancer Related Fatigue in Children and Adolescents With Central Nervous System Tumors
Study Start Date : September 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Fatigue
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acupuncture
Eight sessions of weekly acupuncture
Other: Acupuncture
Eight session of weekly acupuncture

Primary Outcome Measures :
  1. cancer-related fatigue [ Time Frame: Participants will be on-study for up to 14 weeks. . No follow-up will be required after the completion of the study. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572168

United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Rishi Lilla, MD Ann & Robert H Lurie Children's Hospital of Chicago

Responsible Party: Rishi Lulla, Prinicipal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago Identifier: NCT01572168     History of Changes
Other Study ID Numbers: 2011-14423
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago:

Additional relevant MeSH terms:
Signs and Symptoms