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Traditional Chinese Medicine

Acupuncture for Breast Cancer Survivors

Phase 1

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with histologically confirmed stage 0, I, II, or III breast cancer

Self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month with an average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance)

Must not have

Failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study

Bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if acupuncture can help breast cancer survivors improve their quality of life.

Who is the study for?

This trial is for English-speaking women over 18 who've had stage 0-III breast cancer, finished primary treatment within the last month, and are on endocrine therapy. They must have moderate to severe pain, fatigue, sleep issues, depression, hot flashes or anxiety. Excluded are those with bleeding disorders, inability to attend weekly acupuncture sessions, certain psychiatric or medical conditions that affect assessments (like dementia), and those pregnant or planning pregnancy.

What is being tested?

The study is examining how feasible it is to include acupuncture as a regular treatment in health centers for breast cancer survivors dealing with symptoms like pain and fatigue after their main cancer treatments have ended.

What are the potential side effects?

Acupuncture may cause minor side effects such as bruising at needle sites, light-headedness during treatment sessions. Serious side effects are rare but can include infections or injury if not performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with early-stage breast cancer.

Select...

I've had significant pain, fatigue, sleep issues, depression, hot flashes, or anxiety recently.

Select...

I finished my main cancer treatment last month and am now on hormone therapy.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot commit to weekly acupuncture clinic visits.

Select...

I have a bleeding disorder like hemophilia.

Select...

My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability for Treating Multiple Symptoms with Acupuncture

Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.

The numbers of study participants being recruited and retained (Feasibility)

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acupuncture groupExperimental Treatment1 Intervention

Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.

Group II: Usual care groupActive Control1 Intervention

Participants will continue to receive their usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240

0 / 7Eligibility criteria met