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Acupuncture for the Immune System in Radiation Cancer Patients

Primary Purpose

Gastrointestinal Neoplasms, Urogenital Neoplasms

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Medical Acupuncture
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring Radiotherapy, Acupuncture, Immune System

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Cancer Agency - Vancouver Island Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard treatment

Acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in immune biomarker levels
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.

Secondary Outcome Measures

Changes in Symptom Scores
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.

Full Information

First Posted
August 23, 2011
Last Updated
May 22, 2015
Sponsor
British Columbia Cancer Agency
Collaborators
BC Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01422928
Brief Title
Acupuncture for the Immune System in Radiation Cancer Patients
Official Title
Does Radiation Therapy Adversely Affect the Immune System, and Can Acupuncture Ameliorate the Effect? A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not approved by research ethics board.
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
BC Cancer Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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?
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Urogenital Neoplasms
Keywords
Radiotherapy, Acupuncture, Immune System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
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
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Medical Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in immune biomarker levels
Description
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
Changes in Symptom Scores
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan T W Lim, MD
Organizational Affiliation
BC Cancer Agency and University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency - Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada

12. IPD Sharing Statement

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Acupuncture for the Immune System in Radiation Cancer Patients

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