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Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Primary Purpose

Fatigue

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Acupuncture

Placebo Acupuncture

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Cancer, Fatigue, Acupuncture

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy).
Patients must have received chemotherapy.
Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy.
At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire.
Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above.

Exclusion Criteria:

Anemia, defined as Hb<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks.
Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter.
Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression.
Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
Acupuncture in the previous six weeks.
Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors [SSRIs])/anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.

Sites / Locations

Alta Bates Summit Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

Acupuncture

Placebo Acupuncture

Outcomes

Primary Outcome Measures

To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo

Secondary Outcome Measures

To examine the long term effects of acupuncture treatment on fatigue

To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment

To examine the effect of acupuncture on levels of physical activity and quality of life

Full Information

NCT ID

NCT00658034

First Posted

April 8, 2008

Last Updated

October 25, 2011

Sponsor

Alta Bates Summit Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00658034

Brief Title

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Official Title

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alta Bates Summit Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, placebo controlled study in cancer patients reporting fatigue persisting for at least two months following completion of chemotherapy. Subjects will receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.

6. Conditions and Keywords

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

Fatigue

Keywords

Cancer, Fatigue, Acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Acupuncture

Arm Title

Arm Type

Sham Comparator

Arm Description

Placebo Acupuncture

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Intervention Description

Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.

Intervention Type

Procedure

Intervention Name(s)

Placebo Acupuncture

Intervention Description

Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted. Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture.

Primary Outcome Measure Information:

Title

To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo

Time Frame

six weeks

Secondary Outcome Measure Information:

Title

To examine the long term effects of acupuncture treatment on fatigue

Time Frame

six months

Title

To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment

Time Frame

six months

Title

To examine the effect of acupuncture on levels of physical activity and quality of life

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy). Patients must have received chemotherapy. Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy. At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire. Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above. Exclusion Criteria: Anemia, defined as Hb<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks. Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter. Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression. Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy. Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment. Acupuncture in the previous six weeks. Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors [SSRIs])/anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Matecki, MD

Phone

(510) 204-6402

MateckA@Sutterhealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Nick Humphrey, BA

Phone

(510) 204-3428

Humphrn2@sutterhealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Matecki, MD

Organizational Affiliation

Alta Bates Summit Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alta Bates Summit Comprehensive Cancer Center

City

Berkeley

State/Province

California

ZIP/Postal Code

94704

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Office

Phone

510-204-3428

First Name & Middle Initial & Last Name & Degree

Amy Matecki, MD

First Name & Middle Initial & Last Name & Degree

Ji Jill Chen, MD

12. IPD Sharing Statement

Learn more about this trial

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

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