Advanced CancerNCT04398875
Adjunctive Effect of Acupuncture for Advanced Cancer Patients With Palliative Care: a Three-arm Randomized Trial
A study of Advanced Cancer, run by The University of Hong Kong.
Trial summary
The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV;
- Aged 18 years or above;
- Expected survival time longer than 16 weeks;
Who cannot join
- Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count < 35000/µL; INR > 1.5; hemoglobin ≤ 90 g/dL; white blood cell count ≤ 4x109/L;
- Uncontrolled active skin infection;
- Needle phobia;
- Inability to read and understand Chinese;
- Not signed written informed consent.
- Receiving surgery during the whole study period;
- Receiving acupuncture treatment in the last 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: a Three-arm Pragmatic Randomized Trial
The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).
Read the detailed description
After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.
- Conditions
- Advanced Cancer
- Being tested
- Acupuncture and standard care (ASC), Sham acupuncture and standard care (SSC), Standard care (SC)
- Keywords
- advanced cancer, palliative care, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and standard care (ASC)Other
A semi-standardized treatment protocol and standard care will be employed.
Sham acupuncture and standard care (SSC)Other
Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.
Standard care (SC)Other
Standard care will be employed.
| Study group | Role | What they receive |
|---|---|---|
| ASC | Experimental | Traditional manual acupuncture with standard care (ASC) will be provided. Subjects in the ASC group will receive 9 sessions of acupuncture and standard care for 3 weeks. A semi-standardized acupuncture treatment protocol (combined fixed acupoints with additional acupoints by symptom differentiation) will be employed. The fixed acupuncture points including, Guanyuan (CV4), Xuanzhong(GB39), Sanyinjiao (SP6), Yinlingquan (SP9), Zusanli (ST36), Yingtang (EX-HN3), Baihui (GV20), and Qihai (CV6) will be used in every session. Receives: Other: Acupuncture and standard care (ASC) |
| SSC | Sham comparator | Sham acupuncture plus standard care (SSC) will be provided. Subjects in the SSC group will receive 9 sessions of sham acupuncture and standard care for 3 weeks. The Streitberger sham acupuncture will be employed. The selection of acupoints is the same as ASC. Receives: Other: Sham acupuncture and standard care (SSC) |
| SC | Placebo comparator | Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks. Receives: Other: Standard care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the symptom improvments
The Edmonton Symptom Assessment System (ESAS) is used to rate the intensity of nine common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)
Measured: Change from baseline score at 3 weeks
Secondary outcomes (6)
EORTC QLQ-C15-PAL
The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL)
Measured: weeks 0, 3, 7 and 11
Numeric Rating Scale
The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm)
Measured: weeks 0, 3, 7 and 11
Fatigue
The Chinese version of Brief Fatigue Inventory (BFI) is a 9-item, 11-point rating scale developed to assess subjective fatigue.
Measured: weeks 0, 3, 7 and 11
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items. Each item is scored from 0-3. Total score ranges between 0 and 21 for either anxiety or depression.
Measured: weeks 0, 3, 7 and 11
The Insomnia Severity Index
The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28.
Measured: weeks 0, 3, 7 and 11
Symptom improvments
The Edmonton Symptom Assessment System (ESAS) consists of 9 common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)
Measured: weeks 0, 1, 2, 7 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyong CHEN, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398875
- Sponsor's protocol ID
- UW 19-822
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen H, So TH, Cho WC, Qin Z, Ma CH, Li SG, Yang Z, Jiang F, Wu J, Zhang ZJ, Kong FM, Lao L. The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: Study Protocol for a 3-Arm Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211012749. doi: 10.1177/15347354211012749.
PubMed 33957783
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: a Three-arm Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT04398875
- Acronym / sponsor ID
- UW 19-822
- Conditions
- Advanced Cancer
- Keywords
- advanced cancer, palliative care, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 May 2020 (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 aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).
Detailed description
After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASC | Experimental | Other: Acupuncture and standard care (ASC)Traditional manual acupuncture with standard care (ASC) will be provided. Subjects in the ASC group will receive 9 sessions of acupuncture and standard care for 3 weeks. A semi-standardized acupuncture treatment protocol (combined fixed acupoints with additional acupoints by symptom differentiation) will be employed. The fixed acupuncture points including, Guanyuan (CV4), Xuanzhong(GB39), Sanyinjiao (SP6), Yinlingquan (SP9), Zusanli (ST36), Yingtang (EX-HN3), Baihui (GV20), and Qihai (CV6) will be used in every session. |
| SSC | Sham comparator | Other: Sham acupuncture and standard care (SSC)Sham acupuncture plus standard care (SSC) will be provided. Subjects in the SSC group will receive 9 sessions of sham acupuncture and standard care for 3 weeks. The Streitberger sham acupuncture will be employed. The selection of acupoints is the same as ASC. |
| SC | Placebo comparator | Other: Standard care (SC)Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV;
- Aged 18 years or above;
- Expected survival time longer than 16 weeks;
Key exclusion criteria (7 listed)
- Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count < 35000/µL; INR > 1.5; hemoglobin ≤ 90 g/dL; white blood cell count ≤ 4x109/L;
- Uncontrolled active skin infection;
- Needle phobia;
- Inability to read and understand Chinese;
- Not signed written informed consent.
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 |
|---|---|---|
| Acupuncture and standard care (ASC)A semi-standardized treatment protocol and standard care will be employed. | Other | ASC |
| Sham acupuncture and standard care (SSC)Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied. | Other | SSC |
| Standard care (SC)Standard care will be employed. | Other | SC |
Primary outcome
Change of the symptom improvments
Time frame: Change from baseline score at 3 weeks
The Edmonton Symptom Assessment System (ESAS) is used to rate the intensity of nine common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom)
6 secondary outcomes
EORTC QLQ-C15-PAL
Time frame: weeks 0, 3, 7 and 11
Numeric Rating Scale
Time frame: weeks 0, 3, 7 and 11
Fatigue
Time frame: weeks 0, 3, 7 and 11
The Hospital Anxiety and Depression Scale
Time frame: weeks 0, 3, 7 and 11
The Insomnia Severity Index
Time frame: weeks 0, 3, 7 and 11
Symptom improvments
Time frame: weeks 0, 1, 2, 7 and 11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: PubMed 33957783Chen H, So TH, Cho WC, Qin Z, Ma CH, Li SG, Yang Z, Jiang F, Wu J, Zhang ZJ, Kong FM, Lao L. The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: Study Protocol for a 3-Arm Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211012749. doi: 10.1177/15347354211012749.
- 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.
Haiyong CHEN, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study of Advanced Cancer, run by The University of Hong Kong.
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 3 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 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Haiyong CHEN, PhD (852-39176413, haiyong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the symptom improvments (time frame: Change from baseline score at 3 weeks). 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 NCT04398875, which also lists 1 linked publication.
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 21 May 2020.