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A Phase II Study of Acupuncture for the Treatment of Cancer Related Fatigue in Children and Adolescents With Central Nervous System Tumors

Phase 2
8 Years
21 Years
Open (Enrolling)

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Trial Information

A Phase II Study of Acupuncture for the Treatment of Cancer Related Fatigue in Children and Adolescents With Central Nervous System Tumors

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

cancer-related fatigue

Outcome Time Frame:

Participants will be on-study for up to 14 weeks. . No follow-up will be required after the completion of the study.

Safety Issue:


Principal Investigator

Rishi Lilla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Childrens Memorial Hospital


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

Related Keywords:

  • Fatigue
  • Fatigue
  • Fatigue
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Children's Memorial HospitalChicago, Illinois  60614