Stomach NeoplasmsNCT03753399
Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study
A study testing acupuncture in people with Stomach Neoplasms, run by Guangzhou University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesChina
- Study dates
- 4 Jan 2019to 27 Apr 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
- 2.Pathological stage II or stage III；
- 3.Without tumor recurrence confirmed by image examination;
- 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
- 5.Age:18~75 years old；
- 6.ECOG score≤ 2；
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- 7. Normal organs function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min； 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN；
- 8. Can understand the study well and finish the questionnaires in this study;
- 9. With the written informed consent.
Who cannot join
- 1. Can not finish the baseline assessment;
- 2. Needle phobia;
- 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
- 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
- 5. Implanted with heart pacemaker;
- 6. Has accepted neoadjuvant radiotherapy before surgery;
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- 7. Planning to accept adjuvant radiotherapy after surgery;
- 8. With active infection;
- 9. Acupuncture treatment within the previous 6 weeks;
- 10.Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, 210000
About this study
Official title: Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.
- Conditions
- Stomach Neoplasms
- Being tested
- acupuncture
- Keywords
- Gastric cancer, Acupuncture, Quality of life, Adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.
| Study group | Role | What they receive |
|---|---|---|
| High-dose acupuncture | Experimental | Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks Receives: Procedure: acupuncture |
| Low-dose acupuncture | Experimental | Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks Receives: Procedure: acupuncture |
| Usual care | No intervention | Chemotherapy without acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-Gastric Trial Outcome Index (TOI)
FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Chinese version of Edmonton symptom assessment scale (C-ESAS)
Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
Measured: At the end of Cycle 3 (each cycle is 21 days)
Average trajectory of FACT-Gastric TOI over time
FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
Measured: Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).
Average trajectory of C-ESAS over time
Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
Measured: Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.
Measured: Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens.
Adherence to chemotherapy
Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy
Measured: At the end of 3 cycles of treatment (21 days for each cycle).
Concentration of Inflammatory factors in plasma detected with liquid chip
Plasma will be stored at -80℃. Inflammatory factors in plasma will be detected using a liquid chip panel when all patients have finished treatment. the panel is planned to contain 45 inflammatory factors and cytokines, including BDNF, EGF, Eotaxin, FGF-basic, GM-CSF, GROα, HGF, IFNγ, IFNα, IL-1RA, IL-1β, IL-1α, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1α, MIP-1β, NGFβ, PDGF-BB, PLGF, RANTES, SCF, SDF1α, TNFα, TNFβ, VEGF-A, VEGF-D. The panel may be changed at detection according to possible new public articles or reports.
Measured: At the end of 3 cycles of treatment (21 days for each cycle).
Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry
Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry
Measured: At the end of 3 cycles of treatment (21 days for each cycle).
Concentration of Circulating CD8+ T lymph cells detected using flow cytometry
CD8+ T lymph cells in peripheral blood will be detected using flow cytometry
Measured: At the end of 3 cycles of treatment (21 days for each cycle).
Number of Circulating tumor cells detected using microfluidic chip
Circulating tumor cells in peripheral blood will be detected using microfluidic chip
Measured: At the end of 3 cycles of treatment (21 days for each cycle).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start4 Jan 2019
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Nanjing University of Chinese Medicine
- Responsible party
- Principal investigator, Haibo Zhang, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753399
- Sponsor's protocol ID
- 2018KT1226
- Other IDs
- 2017YFC1700603
- Status last verified
- May 2021
- First submitted
- 16 Nov 2018
- Last updated
- 20 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study
- ClinicalTrials.gov ID
- NCT03753399
- Acronym / sponsor ID
- 2018KT1226
- Conditions
- Stomach Neoplasms
- Keywords
- Gastric cancer, Acupuncture, Quality of life, Adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Nanjing University of Chinese Medicine
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 27 Nov 2018 (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.
This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose acupuncture | Experimental | Procedure: acupunctureAcupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks |
| Low-dose acupuncture | Experimental | Procedure: acupunctureAcupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks |
| Usual care | No intervention | –Chemotherapy without acupuncture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
- 2.Pathological stage II or stage III；
- 3.Without tumor recurrence confirmed by image examination;
- 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
- 5.Age:18~75 years old；
Key exclusion criteria (10 listed)
- 1. Can not finish the baseline assessment;
- 2. Needle phobia;
- 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
- 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
- 5. Implanted with heart pacemaker;
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 |
|---|---|---|
| acupunctureAcupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints. | Procedure or surgery | High-dose acupuncture, Low-dose acupuncture |
Primary outcome
FACT-Gastric Trial Outcome Index (TOI)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
Chinese version of Edmonton symptom assessment scale (C-ESAS)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
Average trajectory of FACT-Gastric TOI over time
Time frame: Baseline (at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle).
FACT-Gastric Scoring is designed for measurement of quality of life (QoL) for gastric cancer patients. FACT-Gastric TOI is composed of PHYSICAL WELL BEING （PWB） SUBSCALE, FUNCTIONAL WELL BEING （PWB）SUBSCALE and GASTRIC CANCER SUBSCALE（GaCS）of the FACT-Gastric Scoring. The range of FACT-Gastric TOI is 0-132. The higher the score, the better the quality of life.
Average trajectory of C-ESAS over time
Time frame: Everyday in the first week, then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle)
Chinese version of Edmonton symptom assessment scale (C-ESAS) is a questionnaire used for symptom assessment in cancer patients. C-ESAS is composed of 11 items with score range of 0-10 for each item. The higher the score, the worse the symptom is. We don't include inching item in our study because the inching is common in gastrointestinal department patients rather than cancer patients.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Adverse events will be assessed during the period of 3 cycles of treatment (21 days for each cycle), since the date of randomization. Adverse events will be recorded once any side effect happens.
Adherence to chemotherapy
Time frame: At the end of 3 cycles of treatment (21 days for each cycle).
Concentration of Inflammatory factors in plasma detected with liquid chip
Time frame: At the end of 3 cycles of treatment (21 days for each cycle).
Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry
Time frame: At the end of 3 cycles of treatment (21 days for each cycle).
Concentration of Circulating CD8+ T lymph cells detected using flow cytometry
Time frame: At the end of 3 cycles of treatment (21 days for each cycle).
Number of Circulating tumor cells detected using microfluidic chip
Time frame: At the end of 3 cycles of treatment (21 days for each cycle).
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 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Stomach Neoplasms, run by Guangzhou University of Traditional Chinese Medicine at 3 sites in China.
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 9 inclusion and 10 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
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?
FACT-Gastric Trial Outcome Index (TOI) (time frame: At the end of Cycle 3 (each cycle is 21 days)). 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 20 May 2021.