Acupuncture for the Immune System in Radiation Cancer Patients

NCT01422928 | Withdrawn Phase 3

• 1 other identifier: BCCA- H10-02105
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.Does RT reduce immune biomarkers in treated subjects?
2. 2.Which biomarkers are most affected by treatment?
3. 3.Is acupuncture a feasible option to help ameliorate any biomarker effects?
4. 4.Does RT affect subject symptoms?
5. 5.Is acupuncture a feasible option to help ameliorate any symptom effects?

Conditions

Gastrointestinal Neoplasms; Urogenital Neoplasms

Keywords

Radiotherapy; Acupuncture; Immune System

Outcome Measures

Primary Outcomes (1)

• Changes in immune biomarker levels

  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.

  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 (1)

• Changes in Symptom Scores

  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

Study Arms (2)

Standard treatment

NO INTERVENTION

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

Acupuncture

EXPERIMENTAL

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

Procedure: Medical Acupuncture

Interventions

Medical Acupuncture 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.

Acupuncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• scheduled to receive RT for a period of less than 4 weeks
• expected survival period is less than 12 months
• are on anticoagulants

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator

Study Sites (1)

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jan T W Lim, MD

  BC Cancer Agency and University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 25, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

CA (1)