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NCT Number: NCT04360577

Acupuncture for QoL and Symptoms in Gastric Cancer During 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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foshan First People's Hospital, Foshan, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Acupuncture

Procedure

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).

Primary outcomes

  1. Total AUC of FACT-Gastric TOI

    Time frame: At the end of Cycle 3 ( 21 days for one 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 (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.

Secondary outcomes

  1. 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 (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.

  2. Total AUC of FACT-Gastric Scoring

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

    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.

  3. Average trajectory of FACT-Gastric Scoring 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. 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.

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

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

    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.

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

    Time frame: Baseline(at randomization), once a week during the 3 cycles of treatment (21 days for 1 cycle)

    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.

  6. Total AUC of Modified Edmonton Symptom Assessment Scale

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

    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.

  7. Average trajectory of Modified Edmonton Symptom Assessment Scale

    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)

    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.

Other outcomes

  1. Concentration of circulating myeloid-derived suppressor cells

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

    Myeloid-derived suppressor cells in peripheral blood will be detected using flow cytometry

  2. Concentration of circulating Treg cells

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

    Treg cells in peripheral blood will be detected using flow cytometry

  3. Number of Circulating tumor cells

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

    Circulating tumor cells in peripheral blood will be detected using microfluidic chip

  4. 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.

    Treatment-emergent adverse events is defined as any adverse events happened after randomization. The severity is validated using NCI-CTCAE V4.0.

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Affiliated Hospital of Nanjing University of Chinese Medicine
  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • First Affiliated Hospital, Sun Yat-Sen University
  • First People's Hospital of Foshan
  • Guangdong Provincial People's Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • Southern Medical University, China
  • The First Affiliated Hospital of Guangzhou Medical University
  • Yuebei People's Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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