Clinical trial NCT01422928: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastrointestinal Neoplasms
Urogenital Neoplasms
Keywords: Radiotherapy
Acupuncture
Immune System
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: BC Cancer Foundation
First posted: 2011-08-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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?

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.

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

Primary outcomes:
measure: Changes in immune biomarker levels
timeFrame: 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 outcomes:
measure: Changes in Symptom Scores
timeFrame: 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
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: BC Cancer Agency - Vancouver Island Centre
state: British Columbia
Study officials:
affiliation: BC Cancer Agency and University of British Columbia
name: Jan T W Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: