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Acupuncture for the Immune System in Radiation Cancer Patients

22. maj 2015 opdateret af: British Columbia Cancer Agency

Does Radiation Therapy Adversely Affect the Immune System, and Can Acupuncture Ameliorate the Effect? A Pilot Study

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?

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Research indicates that patients undergoing curative RT for various cancers experience adverse immune effects, as indicated by reduced biomarker levels and activity. RT has been observed to cause a striking reduction in total lymphocyte count, affecting mainly the T-cells. Furthermore, the reduction in the lymphocyte count after RT has been correlated with poorer outcome for bladder cancer, head and neck cancer, uterine cancer, and brain metastases.

Research into the use of complementary and alternative medicine (CAM) has been conducted to determine the utility of these treatments in addressing the unmet needs of many patients with cancer. There is preliminary evidence that acupuncture, in particular, is successful at improving many cancer and treatment associated effects. Earlier studies have indicated that acupuncture can play a role in regulating immune system response to various morbidities, including chemotherapy induced immunosuppression. However, little research has examined is potential for radiation therapy patients

This pilot study aims to assess a wide range of general immune biomarkers to identify biomarkers most affected by RT. Through use of a symptom assessment survey, changes in self reported symptoms will also be recorded. The feasibility of acupuncture as a strategy to ameliorate any adverse immune or symptom effects will also be examined. This information could be very useful in planning future studies on RT and the immune system, or the potential immune benefits of acupuncture.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • BC Cancer Agency - Vancouver Island Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients who will receive ≥ 4 weeks of curative intent long course RT for a GI or GU malignancy
  • patients may or may not have received / be receiving adjuvant chemotherapy
  • anticipated survival of at least 12 months
  • able to visit the BCCA VIC for treatment and 2 follow up visits

Exclusion Criteria:

  • scheduled to receive RT for a period of less than 4 weeks
  • expected survival period is less than 12 months
  • are on anticoagulants

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard treatment

Patients receiving standard radiation therapy for gastrointestinal or urogenital cancers.

All subjects will be asked to give 20 mL of blood and complete the Edmonton Symptom Assessment Form (ESAS) on 3 occasions:

  • before radiation
  • at 1st follow up 4-10 weeks after radiation completion
  • at second follow up 6 months after 1st follow up
Eksperimentel: Acupuncture

Patients receiving standard radiation therapy for gastrointestinal or urogenital cancers with concurrent acupuncture once a week for 4 weeks.

All subjects will be asked to give 20 mL of blood and complete the Edmonton Symptom Assessment Form (ESAS) on 3 occasions:

  • before radiation
  • at 1st follow up 4-10 weeks after radiation completion
  • at second follow up 6 months after 1st follow up
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in immune biomarker levels
Tidsramme: As measured using 3 blood samples collected: before radiation; at 1st follow up 4-10 weeks after radiation completion; at second follow up 6 months after 1st follow up
Change in 21 immune cell types after RT (levels before RT - levels 1st follow up) will be analyzed for controls (to determine if RT reduces immune markers) and experimentals (to determine if acupuncture ameliorates RT effects). Results will be analyzed to determine which biomarkers experienced the largest changes for controls (to identify biomarkers affected by RT) and experimentals (to determine which biomarkers are particularly improved by acupuncture). Change in cell levels during follow up (levels 1st follow up - levels 2nd follow up), will be analyzed to determine duration of changes.
As measured using 3 blood samples collected: before radiation; at 1st follow up 4-10 weeks after radiation completion; at second follow up 6 months after 1st follow up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Symptom Scores
Tidsramme: As measured using the Edmonton Symptom Assessment Scores (ESAS) completed: before radiation; at 1st follow up 4-10 weeks after radiation completion; at second follow up 6 months after 1st follow up
The change in ESAS following treatment (ESAS before treatment - ESAS at first follow up) will be analyzed for control subjects (to determine if RT affects subject symptoms) and experimental subjects (to determine if acupuncture ameliorates any symptom effects). For each subject, results will be analyzed for the change in the total ESAS after treatment, as well as the largest change in ESAS for any single symptom. Also, change in ESAS in the follow up period (ESAS at first follow up - ESAS at second follow up), will be analyzed in order to determine the duration of any changes.
As measured using the Edmonton Symptom Assessment Scores (ESAS) completed: before radiation; at 1st follow up 4-10 weeks after radiation completion; at second follow up 6 months after 1st follow up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

British Columbia Cancer Agency

Samarbejdspartnere

BC Cancer Foundation

Efterforskere

  • Ledende efterforsker: Jan T W Lim, MD, BC Cancer Agency and University of British Columbia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2010

Primær færdiggørelse (Forventet)

1. december 2013

Studieafslutning (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

23. august 2011

Først indsendt, der opfyldte QC-kriterier

23. august 2011

Først opslået (Skøn)

25. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BCCA- H10-02105

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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