Acupuncture for the Immune System in Radiation Cancer Patients

NCT ID: NCT01422928

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-12-31

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.

Conditions

Gastrointestinal Neoplasms; Urogenital Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Acupuncture

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

Group Type: EXPERIMENTAL

Medical Acupuncture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BC Cancer Foundation

OTHER

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan T W Lim, MD

Role: PRINCIPAL_INVESTIGATOR

BC Cancer Agency and University of British Columbia

Locations

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, Canada

Countries

Canada

Other Identifiers

BCCA- H10-02105

Identifier Type: -

Identifier Source: org_study_id