CancerSACCNCT05929690
Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients
A study testing Self-acupuncture in people with Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Self-acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Nov 2023to Dec 2024
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients due to receive radical (curative) intravenous chemotherapy (any chemotherapy regime).
- Patients of either gender and older than 16 years old.
- Patients with any cancer diagnosis.
- Patients willing to participate in the study and be randomised to one of the two treatment arms.
- Patients willing to attend the self-acupuncture workshop, and self-administer acupuncture, if assigned to the intervention.
Who cannot join
- Palliative patients.
- Patients unwilling to participate (for instance due to needle phobia).
- Patients currently receiving acupuncture.
- Patients with a platelet count <20 000mm.
- Patients with a white blood cell count <1000mm.
- Patients with severe clotting dysfunction or who bruise spontaneously.
- Patients unable to complete the questionnaires as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
UCH Macmillan Cancer Centre
London
John Hughes, 02034488883, john.hughes8@nhs.net
About this study
Official title: A Feasibility Trial of Self-Acupuncture for Chemotherapy Cancer Patients (SACC Trial)
The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching cancer patients to self-administer acupuncture to alleviate symptoms of cancer and the side effects of conventional chemotherapy treatment. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) self-acupuncture in addition to standard care or 2) standard care alone. Participants randomised to the self-acupuncture arm will be asked to attend a 1.5 hour group workshop delivered by an experienced practitioners and teachers of self-acupuncture. Participants allocated to standard care will be offered training in self-acupuncture once the trial is complete to address any ongoing side effects from their cancer and its treatment. Patients will be recruited at the initiation of their chemotherapy cancer treatment from UCH Macmillan Cancer Centre. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of chemotherapy treatment, and 3 months post chemotherapy treatment. At the end of chemotherapy treatment participants will also be asked to take part in a qualitative telephone interview to explore their views on the design of the study and if allocated to self-acupuncture their views on the intervention. At 3 months post chemotherapy treatment those allocated to self-acupuncture will be invited to participate in a second qualitative interview to explore the long-term practice and effects of self-acupuncture. Qualitative interviews will also be conducted with stakeholders (acupuncturists delivering workshops and UCH Macmillan Cancer Centre staff) to explore their views on the feasibility of teaching cancer patients self-acupuncture.
- Conditions
- Cancer
- Being tested
- Self-acupuncture
- Keywords
- cancer, acupuncture, feasibility trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-acupunctureOther
Participants be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total).
| Study group | Role | What they receive |
|---|---|---|
| Standard care plus self-acupuncture | Experimental | Participants randomised to the self-acupuncture arm will be asked to attend a group workshop. All participants will be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total). Participants will be asked to needle the points 2-3 times a week throughout their cancer treatment and for 3 months post treatment. Receives: Other: Self-acupuncture |
| Standard care | No intervention | Chemotherapy patients allocated to standard care will receive no additional treatments. 'Standard care' for all patients will be consistent with current best practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 Item (EORTC QLQ-C30)
This is a well-validated quality of life questionnaire focusing on functional assessment. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
Measured: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
Multidimensional Fatigue Inventory (MFI)
The MFI is a well-validated scale measuring general fatigue including the dimensions of physical and mental fatigue, activity, and motivation. The questionnaire comprises 20 items for which the person must specify the extent to which the particular statements relates to them on a five-point scale, ranging from Yes, that is true to No, that is not true.
Measured: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
Memorial Symptom Assessment Scale
This is a multidimensional scale which evaluates 32 physical and psychological symptoms associated with cancer and its treatment.
Measured: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
Visual Analogue Scale of Quality of Life
The Visual Analogue Scale (VAS) is a commonly used outcome measurement to monitor variations in patient reported quality of life.
Measured: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start16 Nov 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Hughes, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929690
- Sponsor's protocol ID
- 152103
- Acronym
- SACC
- Status last verified
- May 2024
- First submitted
- 6 May 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Self-Acupuncture for Chemotherapy Cancer Patients (SACC Trial)
- ClinicalTrials.gov ID
- NCT05929690
- Acronym / sponsor ID
- SACC / 152103
- Conditions
- Cancer
- Keywords
- cancer, acupuncture, feasibility trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- 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.
The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching cancer patients to self-administer acupuncture to alleviate symptoms of cancer and the side effects of conventional chemotherapy treatment. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) self-acupuncture in addition to standard care or 2) standard care alone. Participants randomised to the self-acupuncture arm will be asked to attend a 1.5 hour group workshop delivered by an experienced practitioners and teachers of self-acupuncture. Participants allocated to standard care will be offered training in self-acupuncture once the trial is complete to address any ongoing side effects from their cancer and its treatment. Patients will be recruited at the initiation of their chemotherapy cancer treatment from UCH Macmillan Cancer Centre. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of chemotherapy treatment, and 3 months post chemotherapy treatment. At the end of chemotherapy treatment participants will also be asked to take part in a qualitative telephone interview to explore their views on the design of the study and if allocated to self-acupuncture their views on the intervention. At 3 months post chemotherapy treatment those allocated to self-acupuncture will be invited to participate in a second qualitative interview to explore the long-term practice and effects of self-acupuncture. Qualitative interviews will also be conducted with stakeholders (acupuncturists delivering workshops and UCH Macmillan Cancer Centre staff) to explore their views on the feasibility of teaching cancer patients self-acupuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care plus self-acupuncture | Experimental | Other: Self-acupunctureParticipants randomised to the self-acupuncture arm will be asked to attend a group workshop. All participants will be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total). Participants will be asked to needle the points 2-3 times a week throughout their cancer treatment and for 3 months post treatment. |
| Standard care | No intervention | –Chemotherapy patients allocated to standard care will receive no additional treatments. 'Standard care' for all patients will be consistent with current best practice. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients due to receive radical (curative) intravenous chemotherapy (any chemotherapy regime).
- Patients of either gender and older than 16 years old.
- Patients with any cancer diagnosis.
- Patients willing to participate in the study and be randomised to one of the two treatment arms.
- Patients willing to attend the self-acupuncture workshop, and self-administer acupuncture, if assigned to the intervention.
Key exclusion criteria (7 listed)
- Palliative patients.
- Patients unwilling to participate (for instance due to needle phobia).
- Patients currently receiving acupuncture.
- Patients with a platelet count <20 000mm.
- Patients with a white blood cell count <1000mm.
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 |
|---|---|---|
| Self-acupunctureParticipants be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total). | Other | Standard care plus self-acupuncture |
Primary outcome
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 Item (EORTC QLQ-C30)
Time frame: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
This is a well-validated quality of life questionnaire focusing on functional assessment. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
Multidimensional Fatigue Inventory (MFI)
Time frame: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
The MFI is a well-validated scale measuring general fatigue including the dimensions of physical and mental fatigue, activity, and motivation. The questionnaire comprises 20 items for which the person must specify the extent to which the particular statements relates to them on a five-point scale, ranging from Yes, that is true to No, that is not true.
Memorial Symptom Assessment Scale
Time frame: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
This is a multidimensional scale which evaluates 32 physical and psychological symptoms associated with cancer and its treatment.
Visual Analogue Scale of Quality of Life
Time frame: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)
The Visual Analogue Scale (VAS) is a commonly used outcome measurement to monitor variations in patient reported quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-acupuncture in people with Cancer, run by University College London Hospitals at 1 site in United Kingdom.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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 United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Hughes (02034488883, john.hughes8@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 Item (EORTC QLQ-C30) (time frame: This scale will measure change at baseline and upon completion of chemotherapy treatment (up to 26 weeks later)). The study lists 4 primary outcomes in all. 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 14 May 2024.