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Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel

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City of Hope

Status

Terminated

Conditions

Stage IIIA Breast Cancer
Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage II Breast Cancer
Stage I Breast Cancer

Treatments

Other: management of therapy complications
Other: questionnaire administration
Other: acupuncture therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01050075
09109
NCI-2010-00103

Details and patient eligibility

About

RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.

Full description

PRIMARY OBJECTIVE:

I. To explore the potential for the use of acupuncture to prevent a worsening of the nerve damage in patients (during treatment) due to paclitaxel as measured by a Neuropathic Pain Symptom Inventory.

SECONDARY OBJECTIVES:

I. Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory tests and nerve conduction tests.

II. Evaluate the improvement observed when treating patients for peripheral neuropathy (post-chemotherapy) with acupuncture based on the same metrics.

III. To correlate objective measures of neuropathy (nerve conduction, quantitative sensory tests, neuropathy composite score, and blood cytokine levels) with the subjective questionnaire/quality of life measures.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.

ARM II: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

  • Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
  • Performance ECOG 0-2 (Karnofsky Performance Status >= 60%)
  • Life expectancy of greater than 6 months
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion

  • Patients with radiologically confirmed stage IV breast cancer
  • Patients who had acupuncture in the previous 8 weeks
  • Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
  • Patients with needle phobia
  • Patients who experienced any peripheral neuropathy prior to chemotherapy
  • Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
  • Patients with diabetes

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

Arm I
Experimental group
Description:
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
Treatment:
Other: acupuncture therapy
Other: questionnaire administration
Other: management of therapy complications
Arm II
Experimental group
Description:
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
Treatment:
Other: acupuncture therapy
Other: questionnaire administration
Other: management of therapy complications

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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