NCT03753399

Brief 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 resection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

November 16, 2018

Last Update Submit

May 19, 2021

Conditions

Stomach Neoplasms

Keywords

Gastric cancerAcupunctureQuality of lifeAdjuvant chemotherapy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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]

    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

    At the end of 3 cycles of treatment (21 days for each cycle).

  • Concentration of Inflammatory factors in plasma detected with liquid chip

    At the end of 3 cycles of treatment (21 days for each cycle).

  • Concentration of circulating myeloid-derived suppressor cells detected with flow cytometry

    At the end of 3 cycles of treatment (21 days for each cycle).

  • Concentration of Circulating CD8+ T lymph cells detected using flow cytometry

    At the end of 3 cycles of treatment (21 days for each cycle).

  • +1 more secondary outcomes

Study Arms (3)

High-dose acupuncture

EXPERIMENTAL

Acupuncture for 7 times every 3 weeks (a cycle of chemotherapy) for 9 weeks

Procedure: acupuncture

Low-dose acupuncture

EXPERIMENTAL

Acupuncture for 3 times every 3 weeks (a cycle of chemotherapy) for 9 weeks

Procedure: acupuncture

Usual care

NO INTERVENTION

Chemotherapy without acupuncture

Interventions

acupuncturePROCEDURE

Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.

High-dose acupunctureLow-dose acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
  • Pathological stage II or stage III；
  • Without tumor recurrence confirmed by image examination;
  • No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
  • Age:18\~75 years old；
  • ECOG score≤ 2；
  • \. 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；
  • \. Can understand the study well and finish the questionnaires in this study;
  • \. With the written informed consent.

You may not qualify if:

  • \. Can not finish the baseline assessment;
  • \. Needle phobia;
  • \. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
  • \. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
  • \. Implanted with heart pacemaker;
  • \. Has accepted neoadjuvant radiotherapy before surgery;
  • \. Planning to accept adjuvant radiotherapy after surgery;
  • \. With active infection;
  • \. Acupuncture treatment within the previous 6 weeks;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 27, 2018

Study Start

January 4, 2019

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

May 20, 2021

Record last verified: 2021-05

Locations

CN(3)