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Acupuncture for the Treatment of Cancer Related Fatigue

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01572168
First received: February 24, 2012
Last updated: July 14, 2014
Last verified: July 2014

February 24, 2012
July 14, 2014
September 2011
February 2015   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01572168 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acupuncture for the Treatment of Cancer Related Fatigue
A Phase II Study of Acupuncture for the Treatment of Cancer Related Fatigue in Children and Adolescents With Central Nervous System Tumors

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Fatigue
Other: Acupuncture
Eight session of weekly acupuncture
Experimental: Acupuncture
Eight sessions of weekly acupuncture
Intervention: Other: Acupuncture

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
February 2015   (final data collection date for primary outcome measure)

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.
Both
8 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572168
2011-14423
No
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Rishi Lilla, MD Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP