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Gastrointestinal NeoplasmsPhase 3NCT01422928

Acupuncture for the Immune System in Radiation Cancer Patients

A Phase 3 study testing Medical Acupuncture in people with Gastrointestinal Neoplasms and Urogenital Neoplasms, run by British Columbia Cancer Agency at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Medical Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Dec 2010to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

About this study

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

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?
Read the 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.

Being tested
Medical Acupuncture
Keywords
Radiotherapy, Acupuncture, Immune System
Medical subject headings
Gastrointestinal Neoplasms, Urogenital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical AcupunctureProcedure or surgery

    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.

Study groups in NCT01422928
Study groupRoleWhat they receive
Standard treatmentNo interventionPatients 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
AcupunctureExperimentalPatients 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
Receives: Procedure: Medical Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Changes in Symptom Scores

    The change in ESAS following treatment (ESAS before treatment - ESAS at first follow up) will be analyzed for control subjects (to determine if RT affects subject symptoms) and experimental subjects (to determine if acupuncture ameliorates any symptom effects). For each subject, results will be analyzed for the change in the total ESAS after treatment, as well as the largest change in ESAS for any single symptom. Also, change in ESAS in the follow up period (ESAS at first follow up - ESAS at second follow up), will be analyzed in order to determine the duration of any changes.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Why it stopped: Study was not approved by research ethics board.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01422928
Sponsor's protocol ID
BCCA- H10-02105
Status last verified
May 2015
First submitted
23 Aug 2011
Last updated
25 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Medical Acupuncture in people with Gastrointestinal Neoplasms and Urogenital Neoplasms, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in immune biomarker levels (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01422928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.

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