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Stomach NeoplasmsNCT04360577

Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

A study testing acupuncture in people with Stomach Neoplasms, run by Guangzhou University of Traditional Chinese Medicine at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. 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
240 participants
Where
11 sitesChina
Study dates
27 May 2020to 9 May 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 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
  • 7. Normal organ 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;
Show all 10Show fewer
  • 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

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Foshan First People's Hospital

    Foshan, Guangdong, 528000

  • The first affiliated hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    Guangzhou, Guangdong

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Sixth affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • The first affiliated hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

    Nanjing, Jiangsu, 210000

  • Yue Bei People's Hospital

    Shaoguan, Guangdong, 512025

  • Fifth affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong, 519000

Other trials in China

About this study

Official title: Effect of Acupuncture for Quality of Life and Symptom Control in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy

In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.

Being tested
acupuncture
Keywords
Gastric Cancer, Acupuncture, Quality of Life, Symptom Burden, 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, combing with electro-acupuncture at Baihui(GV20), Yintang(GV29), Neiguan(PC6), Zusanli(ST36), and Gongsun(SP4).

Study groups in NCT04360577
Study groupRoleWhat they receive
High-dose acupunctureExperimentalAcupuncture for 7 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)
Receives: Procedure: acupuncture
Low-dose acupunctureExperimentalAcupuncture for 3 times every 3 weeks (one cycle of chemotherapy) for 9 weeks (3 cycles of chemotherapy)
Receives: Procedure: acupuncture
Usual careNo interventionChemotherapy without acupuncture

What is being measured

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

  1. Total AUC of FACT-Gastric 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 (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (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. TOI for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.

    Measured: At the end of Cycle 3 ( 21 days for one cycle)

Secondary outcomes (7)

  1. 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 (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (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)

  2. Total AUC of FACT-Gastric Scoring

    FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. The higher the score, the better the quality of life. FACT-Gastric scoring for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.

    Measured: At the end of Cycle 3 ( 21 days for one cycle)

  3. Average trajectory of FACT-Gastric Scoring over time

    FACT-Gastric Scoring is designed for measurement of quality of life(QoL) for gastric cancer patients. It is composed of PHYSICAL WELL BEING (PWB) SUBSCALE, SOCIAL WELL BEING (SWB) SUBSCALE, EMOTIONAL WELL BEING (EWB) SUBSCALE, FUNCTIONAL WELL BEING (FWB) SUBSCALE, and GASTRIC CANCER SUBSCAL (GaCS). The range of FACT-Gastric scoring is 0-184. 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)

  4. Total AUC of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric

    The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. The higher the score, the better the quality of life. GaCS for each patient will be recorded at baseline and once a week during the 3 cycles of chemotherapy (21 days for one cycle). The area under curve (AUCs) for each week are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.

    Measured: At the end of Cycle 3 ( 21 days for one cycle)

  5. Average trajectory of GASTRIC CANCER SUBSCAL (GaCS) of FACT-Gastric

    The GaCS of FACT-Gastric focuses on the symptoms and functions related to gastric cancer specifically. The range of GaCS is 0-76. 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)

  6. Total AUC of Modified Edmonton Symptom Assessment Scale

    Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is. ESAS scoring for each patient will be recorded everyday in the first week, and then once a week in the next 2 weeks during each cycle of chemotherapy (21 days for 1 cycle). The AUCs are calculated by linear interpolation respectively, and then added together for the total AUC during the 3 cycles of chemotherapy.

    Measured: At the end of Cycle 3 ( 21 days for one cycle)

  7. Average trajectory of Modified Edmonton Symptom Assessment Scale

    Edmonton symptom assessment scale (ESAS) is a questionnaire used for symptom assessment in cancer patients. It was composed of 10 items with score range of 0-10 for each item, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, shortness of breath, and other. ESAS was then modified in 2015, with additional symptoms of constipation and sleep. The higher the score, the worse the symptom is.

    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)

Timeline

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

  1. First posted24 Apr 2020
  2. Study start27 May 2020
  3. Primary completion23 Mar 2023
  4. Study completion9 May 2023

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360577
Sponsor's protocol ID
2018KT1226-2
Other IDs
2017YFC1700603
Status last verified
Jun 2024
First submitted
21 Apr 2020
Last updated
12 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD can be obtained from the PI with application after article publication.

Publications

  • Zhu YJ, Chang XS, Wu XY, Wang W, Diao DC, Li Y, Zhang HY, Xiao J, Zhai XH, Yu JL, Wang W, Zhou JX, Huang ZL, Zhang T, Ouyang W, Janjigian YY, Cytryn SL, Xiao ZZ, Liu YH, Zhou R, Ma HC, Chen YD, Peng JJ, Mao JJ, Zhang HB. Electro-acupuncture for quality of life during adjuvant chemotherapy in gastric cancer: a randomized trial. J Natl Cancer Inst. 2026 Apr 1;118(4):603-612. doi: 10.1093/jnci/djaf309.

    PubMed 41143548

  • Chang X, Zhu Y, Zhao W, Liu Y, He Y, Chen Y, Xu D, Mao JJ, Zhang HB. Electro-acupuncture for health-related quality of life and symptoms in patients with gastric cancer undergoing adjuvant chemotherapy (EAGER): a protocol for a multicenter randomized controlled trial. Health Qual Life Outcomes. 2023 Jul 11;21(1):70. doi: 10.1186/s12955-023-02135-9.

    PubMed 37434165

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 11 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 8 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

Total AUC of FACT-Gastric TOI (time frame: At the end of Cycle 3 ( 21 days for one cycle)). 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 NCT04360577, which also lists 2 linked publications.

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 12 Jun 2024.

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