NeoplasmsPhase 3NCT00302185
Acupuncture in Palliative Cancer Care
A Phase 3 study testing Acupuncture and Nurse-led supportive care in people with Neoplasms and Palliative Care, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Research question: Can acupuncture improve symptom control and quality of life (QOL) in patients with advanced incurable cancer? The purposes of this study is to investigate the feasibility of performing a randomized trial with acupuncture in improving symptom control and quality of life (QOL) in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Palliative Care
- What is being tested?
- Acupuncture and Nurse-led supportive care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Mar 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving palliative therapy for incurable cancer
- anticipated survival of at least 3 months
- able to complete ESAS sheet unaided
- ESAS of 5 or more in at least one of the following symptoms; fatigue, depression, anxiety and lack of wellbeing
Who cannot join
- refuse to receive weekly acupuncture for 4 weeks
- refuse to receive nursing support for 4 weeks
- known to have impaired clotting of blood
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5
About this study
Official title: A Feasibility Study in Acupuncture for Symptom Management in Palliative Care.
Research question: Can acupuncture improve symptom control and quality of life (QOL) in patients with advanced incurable cancer?
The purposes of this study is to investigate the feasibility of performing a randomized trial with acupuncture in improving symptom control and quality of life (QOL) in patients with advanced incurable cancer at the BC Cancer Agency, Vancouver Island Centre in Victoria.
We will:
- Evaluate whether subjects who are receiving palliative care for cancer related symptoms can tolerate and complete to a course of acupuncture treatments.
- Evaluate whether it is possible to conduct a study using acupuncture on cancer patients.
Read the detailed description
Patients with advanced cancer suffer from many symptoms which dramatically reduce their Quality of Life (QOL). There have been significant improvements in the management of pain, nausea and constipation, but other common symptoms such as fatigue, anxiety, depression, and a lack of well-being are not readily addressed by conventional therapies. As cancer patients usually present with numerous symptoms, it would be important to try to address all of these globally, instead of only treating individual symptoms that respond well to conventional therapy. Attempts at controlling individual symptoms can also give rise to iatrogenic effects. One well known example is constipation occurring in patients who are on opiate analgesics. Successful treatment from the caregiver's perspective is often scored against each individual symptom that is being treated. From the patient's point of view, it is the interplay of the whole treatment package that succeeds or fails in improving his QOL
In an attempt at treating all of the patient's symptoms, 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 symptoms.
Given the potential to improve symptom control and QOL, it is thought that acupuncture should be investigated to assess its effectiveness and feasibility in symptomatic patients with advanced cancer. Acupuncture should be compared against another intervention, so that the control group would also be receiving attention to their symptoms. As supportive care has been shown to be helpful in ameliorating symptoms in terminal care, acupuncture will be compared against this intervention. Sham acupuncture is not considered to be a good comparison for acupuncture as it is not well tested, and its effects are often indistinguishable from acupuncture. Recently however, some studies have reported the use of novel techniques that prevent acupuncture-naïve patients from distinguishing between acupuncture treatment and placebo. These techniques have yet to be independently validated.
Objectives: 1. To determine feasibility of recruiting patients and running a randomized study that involves acupuncture at the BCCA-VIC. 2. To gather enough data to support a grant application to fund a larger study to look at the effectiveness of acupuncture as adjunctive treatment for the management of symptoms associated with palliative cancer care.
- Conditions
- Neoplasms, Palliative Care
- Being tested
- Acupuncture, Nurse-led supportive care
- Keywords
- Palliative Care, Acupuncture, Symptom Management, Quality of Life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Insertion of sterile, single-use acupuncture needles at 10-20 points including PC.6, HT.7, St.36, SP.6, and LR.3. Needles were connected to an electrical stimulator to mimick traditional manual stimulation with alternating patterns of stimulation for 20 minutes.
Nurse-led supportive careBehavioural
20-30 minutes of supportive attention from an experienced palliative nurse.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led supportive care | Active comparator | Visit with a Palliative Care nurse once weekly for 4 weeks Receives: Behavioral: Nurse-led supportive care |
| Acupuncture | Experimental | Patients received acupuncture once a week for 4 weeks. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Edmonton Symptom Assessment Score (ESAS) after intervention (ESAS at baseline - ESAS at first follow up) will be analysed for each of the 4 symptoms (fatigue, anxiety, depression, a lack of well-being) under investigation. Results will be
Secondary outcomes (3)
Determine the % of patients suitable, and the % of patients who consent to be recruited.
Determine the % of patients who complete all 4 intervention sessions.
Determine the duration of change in ESAS after intervention (ESAS at second and third follow-up - ESAS at first follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJun 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Investigators
- Jan T Lim, MD, Principal investigator, BC Cancer Agency and University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302185
- Sponsor's protocol ID
- BCCAVIC Pal 1
- Status last verified
- Oct 2010
- First submitted
- 13 Mar 2006
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study in Acupuncture for Symptom Management in Palliative Care.
- ClinicalTrials.gov ID
- NCT00302185
- Acronym / sponsor ID
- BCCAVIC Pal 1
- Conditions
- Neoplasms, Palliative Care
- Keywords
- Palliative Care, Acupuncture, Symptom Management, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research question: Can acupuncture improve symptom control and quality of life (QOL) in patients with advanced incurable cancer?
The purposes of this study is to investigate the feasibility of performing a randomized trial with acupuncture in improving symptom control and quality of life (QOL) in patients with advanced incurable cancer at the BC Cancer Agency, Vancouver Island Centre in Victoria.
We will:
- Evaluate whether subjects who are receiving palliative care for cancer related symptoms can tolerate and complete to a course of acupuncture treatments.
- Evaluate whether it is possible to conduct a study using acupuncture on cancer patients.
Detailed description
Patients with advanced cancer suffer from many symptoms which dramatically reduce their Quality of Life (QOL). There have been significant improvements in the management of pain, nausea and constipation, but other common symptoms such as fatigue, anxiety, depression, and a lack of well-being are not readily addressed by conventional therapies. As cancer patients usually present with numerous symptoms, it would be important to try to address all of these globally, instead of only treating individual symptoms that respond well to conventional therapy. Attempts at controlling individual symptoms can also give rise to iatrogenic effects. One well known example is constipation occurring in patients who are on opiate analgesics. Successful treatment from the caregiver's perspective is often scored against each individual symptom that is being treated. From the patient's point of view, it is the interplay of the whole treatment package that succeeds or fails in improving his QOL
In an attempt at treating all of the patient's symptoms, 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 symptoms.
Given the potential to improve symptom control and QOL, it is thought that acupuncture should be investigated to assess its effectiveness and feasibility in symptomatic patients with advanced cancer. Acupuncture should be compared against another intervention, so that the control group would also be receiving attention to their symptoms. As supportive care has been shown to be helpful in ameliorating symptoms in terminal care, acupuncture will be compared against this intervention. Sham acupuncture is not considered to be a good comparison for acupuncture as it is not well tested, and its effects are often indistinguishable from acupuncture. Recently however, some studies have reported the use of novel techniques that prevent acupuncture-naïve patients from distinguishing between acupuncture treatment and placebo. These techniques have yet to be independently validated.
Objectives: 1. To determine feasibility of recruiting patients and running a randomized study that involves acupuncture at the BCCA-VIC. 2. To gather enough data to support a grant application to fund a larger study to look at the effectiveness of acupuncture as adjunctive treatment for the management of symptoms associated with palliative cancer care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led supportive care | Active comparator | Behavioral: Nurse-led supportive careVisit with a Palliative Care nurse once weekly for 4 weeks |
| Acupuncture | Experimental | Procedure: AcupuncturePatients received acupuncture once a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients receiving palliative therapy for incurable cancer
- anticipated survival of at least 3 months
- able to complete ESAS sheet unaided
- ESAS of 5 or more in at least one of the following symptoms; fatigue, depression, anxiety and lack of wellbeing
Key exclusion criteria (3 listed)
- refuse to receive weekly acupuncture for 4 weeks
- refuse to receive nursing support for 4 weeks
- known to have impaired clotting of blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureInsertion of sterile, single-use acupuncture needles at 10-20 points including PC.6, HT.7, St.36, SP.6, and LR.3. Needles were connected to an electrical stimulator to mimick traditional manual stimulation with alternating patterns of stimulation for 20 minutes. | Procedure or surgery | Acupuncture |
| Nurse-led supportive care20-30 minutes of supportive attention from an experienced palliative nurse. | Behavioural | Nurse-led supportive care |
Primary outcome
The change in Edmonton Symptom Assessment Score (ESAS) after intervention (ESAS at baseline - ESAS at first follow up) will be analysed for each of the 4 symptoms (fatigue, anxiety, depression, a lack of well-being) under investigation. Results will be
3 secondary outcomes
Determine the % of patients suitable, and the % of patients who consent to be recruited.
Determine the % of patients who complete all 4 intervention sessions.
Determine the duration of change in ESAS after intervention (ESAS at second and third follow-up - ESAS at first follow up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan T Lim, MD principal investigator
BC Cancer Agency and University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture and Nurse-led supportive care in people with Neoplasms and Palliative Care, 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: finished, as of the sponsor's last update on 20 Oct 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in Edmonton Symptom Assessment Score (ESAS) after intervention (ESAS at baseline - ESAS at first follow up) will be analysed for each of the 4 symptoms (fatigue, anxiety, depression, a lack of well-being) under investigation. Results will be. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2010.