NCT01422928

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Neoplasms
• Urogenital Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Medical Acupuncture	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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-08-25
• Last updated: 2015-05-25

Locations

1 site across 1 country: Canada