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

Phase 3
Open (Enrolling)
Gastrointestinal Neoplasms, Urogenital Neoplasms

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Trial Information

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

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

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.

Inclusion Criteria:

- patients who will receive ≥ 4 weeks of curative intent long course RT for a GI or GU

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in immune biomarker levels

Outcome 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.

Outcome 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

Safety Issue:


Principal Investigator

Jan T W Lim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency and University of British Columbia


Canada: Health Canada

Study ID:

BCCA- H10-02105



Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Gastrointestinal Neoplasms
  • Urogenital Neoplasms
  • Radiotherapy
  • Acupuncture
  • Immune System
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Urogenital Neoplasms