Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastric cancer, Acupuncture, Quality of life, Adjuvant chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

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.

Sites / Locations

The first affiliated hospital, Sun Yat-sen University
Guangdong Provincial Hospital of Chinese Medicine
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

High-dose acupuncture

Low-dose acupuncture

Usual care

Arm Description

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

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

Chemotherapy without acupuncture

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

Adherence to chemotherapy

Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy

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.

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

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

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

CD8+ T lymph cells in peripheral blood will be detected using flow cytometry

Number of Circulating tumor cells detected using microfluidic chip

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

Full Information

NCT ID

NCT03753399

First Posted

November 16, 2018

Last Updated

May 19, 2021

Sponsor

Guangzhou University of Traditional Chinese Medicine

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03753399

Brief Title

Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

Official Title

Effect of Acupuncture for Quality of Life in Patients With Gastric Cancer Undergoing Adjuvant Chemotherapy: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

April 27, 2020 (Actual)

Study Completion Date

April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms

Keywords

Gastric cancer, Acupuncture, Quality of life, Adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

Low-dose acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Chemotherapy without acupuncture

Intervention Type

Procedure

Intervention Name(s)

acupuncture

Intervention Description

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

Primary Outcome Measure Information:

Title

FACT-Gastric Trial Outcome Index (TOI)

Description

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.

Time Frame

At the end of Cycle 3 (each cycle is 21 days)

Title

Chinese version of Edmonton symptom assessment scale (C-ESAS)

Description

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.

Time Frame

At the end of Cycle 3 (each cycle is 21 days)

Title

Average trajectory of FACT-Gastric TOI over time

Description

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.

Time Frame

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

Title

Average trajectory of C-ESAS over time

Description

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.

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)

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

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

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.

Title

Adherence to chemotherapy

Description

Delay of adjuvant chemotherapy, complete rate of adjuvant chemotherapy

Time Frame