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Acupuncture for the Immune System in Radiation Cancer Patients

NCT01422928 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-05-25

No results posted yet for this study

Summary

Purpose/Goal: To investigate how long course radiation therapy (RT), both with or without chemotherapy, affects the immune system, and to determine if acupuncture can modify these effects in patients undergoing curative radiation therapy for gastrointestinal (GI) or genitourinary (GU) cancers.

Clinical or Research Questions:

1. Does RT reduce immune biomarkers in treated subjects?
2. Which biomarkers are most affected by treatment?
3. Is acupuncture a feasible option to help ameliorate any biomarker effects?
4. Does RT affect subject symptoms?
5. Is acupuncture a feasible option to help ameliorate any symptom effects?

Conditions

  • Gastrointestinal Neoplasms
  • Urogenital Neoplasms

Interventions

PROCEDURE

Medical Acupuncture

Subjects will be asked to report symptom concerns. Subjects are requested to wear loose clothing as most acupoints lie at or distal to the elbow and knee. Sterile single use steel needles (ITO Adiquip 0.25 x 4.0 cm) will be inserted to a depth of 1 - 2 cm at acupoints thought to impact positively on the immune system. An ITO ES-160 Electrostimulator will be used to mimic the "pecking" technique of manual stimulation. Following needle insertion by the acupuncturist, a nurse or acupuncture student may assist by attaching electrodes to provide electrical stimulation. A 0.3 ms duration, 4 HZ, alternating current will be delivered with voltage set just below the pain threshold of the patient. After 20 minutes, the needles will be removed. Acupoints will include: * GV.14 * LI.11 (bilateral) * SP.6 (bilateral) * SP.10 (bilateral) * ST.36 (bilateral) Additional points may be added based on the symptom concerns reported.

Sponsors & Collaborators

  • BC Cancer Foundation

    collaborator OTHER

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Jan T W Lim, MD · BC Cancer Agency and University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422928 on ClinicalTrials.gov