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Behavioural Intervention

Electroacupuncture for Symptom Management After Cancer Surgery

N/A

Waitlist Available

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; approximately 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using electroacupuncture can help manage symptoms like pain, nausea, diarrhea, and insomnia in patients who have had a specific type of surgery and chemotherapy. The study will also

Who is the study for?

This trial is for patients who've had Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy to treat cancer. It's designed to see if electroacupuncture can help manage symptoms like pain, nausea, vomiting, diarrhea, and insomnia post-surgery.

What is being tested?

The study tests the use of electroacupuncture as a treatment for managing symptoms after specific cancer surgeries. The goal is to assess how well it works (effectiveness), how safe it is (safety), and whether patients are willing to stick with it (compliance).

What are the potential side effects?

While not explicitly stated in the provided information, common side effects of electroacupuncture may include slight bleeding or bruising at needle sites, dizziness or fainting. Serious side effects are rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; approximately 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; approximately 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; approximately 1.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions

Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited

Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate

+3 more

Secondary study objectives

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3

Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30

+1 more

Other study objectives

Biomarkers - Plasma (pg/mL)

Biomarkers - Plasma BDNF (pg/ml)

Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)

+9 more

Side effects data

From 2007 Phase 2 trial • 57 Patients • NCT00071110

32%

INCREASED DREAM ACTIVITY

29%

HEADACHE

25%

REDUCED DURATION OF SLEEP:

25%

NAUSEA / VOMITING

25%

ORGASMIC DYSFUNCTION

11%

ORTHOSTATIC DIZZINESS

11%

INCREASED DURATION OF SLEEP:

11%

INCREASED TENDENCY TO SWEATING

11%

DIMINISHED SEXUAL DESIRE

PALPITATIONS / TACHYCARDIA

EMOTIONAL INDIFFERENCE

PHOTOSENSITIVITY

ASTHENIA / LASSITUDE / INCREASED FATIGUABILITY

SLEEPINESS / SEDATION

FAILING MEMORY

TENSION / INNER UNREST

DIARRHEA

RASH

PRURITUS

DRY VAGINA

100%

80%

60%

40%

20%

Study treatment Arm

Electroacupuncture (EA)

Sham Acupuncture (SA)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Each participant will attend a total of 8 treatment visits (one visit per week), over the course of 8 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 10 standardized acu-points that were chosen for their therapeutic effects.

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