Acupuncture for the Treatment of Cancer Related Fatigue

NCT01572168 | Terminated Phase 2

• 1 other identifier: 2011-14423
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

Fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Acupuncture

EXPERIMENTAL

Eight sessions of weekly acupuncture

Other: Acupuncture

Interventions

Acupuncture OTHER

Eight session of weekly acupuncture

Acupuncture

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• Cella D, Davis K, Breitbart W, Curt G; Fatigue Coalition. Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol. 2001 Jul 15;19(14):3385-91. doi: 10.1200/JCO.2001.19.14.3385.

  PMID: 11454886 BACKGROUND

• Lai JS, Cella D, Kupst MJ, Holm S, Kelly ME, Bode RK, Goldman S. Measuring fatigue for children with cancer: development and validation of the pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (pedsFACIT-F). J Pediatr Hematol Oncol. 2007 Jul;29(7):471-9. doi: 10.1097/MPH.0b013e318095057a.

  PMID: 17609625 BACKGROUND

• Libonate J, Evans S, Tsao JC. Efficacy of acupuncture for health conditions in children: a review. ScientificWorldJournal. 2008 Jul 13;8:670-82. doi: 10.1100/tsw.2008.86.

  PMID: 18661055 BACKGROUND

• Jindal V, Ge A, Mansky PJ. Safety and efficacy of acupuncture in children: a review of the evidence. J Pediatr Hematol Oncol. 2008 Jun;30(6):431-42. doi: 10.1097/MPH.0b013e318165b2cc.

  PMID: 18525459 BACKGROUND

• Molassiotis A, Sylt P, Diggins H. The management of cancer-related fatigue after chemotherapy with acupuncture and acupressure: a randomised controlled trial. Complement Ther Med. 2007 Dec;15(4):228-37. doi: 10.1016/j.ctim.2006.09.009. Epub 2006 Nov 13.

  PMID: 18054724 BACKGROUND

• Balk J, Day R, Rosenzweig M, Beriwal S. Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. J Soc Integr Oncol. 2009 Winter;7(1):4-11.

  PMID: 19476729 BACKGROUND

• Matecki, A.a.I., David, Acupunture for the Treatment of Chronic Post-Chemotherapy Fatigue. ClinicalTrials.gov, 2008: p. NCT00658034.

  BACKGROUND

MeSH Terms

Conditions

Fatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Rishi Lilla, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: April 6, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)