Acupuncture for the Immune System in Radiation Cancer Patients

Gastrointestinal Neoplasms Clinical Trial

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

Status Withdrawn

Clinical Trial 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?

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms
• Urogenital Neoplasms

• NCT number: NCT01422928
• Study type: Interventional
• Source: British Columbia Cancer Agency
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2010
• Completion date: December 2013