Acupuncture for the Immune System in Radiation Cancer Patients
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:
- Does RT reduce immune biomarkers in treated subjects?
- Which biomarkers are most affected by treatment?
- Is acupuncture a feasible option to help ameliorate any biomarker effects?
- Does RT affect subject symptoms?
- Is acupuncture a feasible option to help ameliorate any symptom effects?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer Agency - Vancouver Island Centre
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 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:
|
|
|
Expérimental: 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:
|
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:
Additional points may be added based on the symptom concerns reported. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in immune biomarker levels
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Symptom Scores
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jan T W Lim, MD, BC Cancer Agency and University of British Columbia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BCCA- H10-02105
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .