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Acupuncture for the Treatment of Cancer Related Fatigue

Primary Purpose

Fatigue

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Fatigue

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

Eight sessions of weekly acupuncture

Outcomes

Primary Outcome Measures

cancer-related fatigue

Secondary Outcome Measures

Full Information

NCT ID

NCT01572168

First Posted

February 24, 2012

Last Updated

February 3, 2016

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT01572168

Brief Title

Acupuncture for the Treatment of Cancer Related Fatigue

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 Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

slow accrual

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

Fatigue

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Eight sessions of weekly acupuncture

Intervention Type

Other

Intervention Name(s)

Acupuncture

Intervention Description

Eight session of weekly acupuncture

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rishi Lilla, MD

Organizational Affiliation

Ann & Robert H Lurie Children's Hospital of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11454886

Citation

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.

Results Reference

background

PubMed Identifier

17609625

Citation

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.

Results Reference

background

PubMed Identifier

18661055

Citation

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.

Results Reference

background

PubMed Identifier

18525459

Citation

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.

Results Reference

background

PubMed Identifier

18054724

Citation

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.

Results Reference

background

PubMed Identifier

19476729

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

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Acupuncture for the Treatment of Cancer Related Fatigue

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