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Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (FFEJJICRF)

Primary Purpose

Cancer-related Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fufang E'Jiao Jiang
placebo containing low-dose fufang E'Jiao Jiang
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer-related Fatigue focused on measuring Traditional Chinese medicine, Fufang E'Jiao Jiang, Randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria:

  1. The age of patients between 18 and 75，gender not limited.
  2. Patients that pathologically diagnosed with colorectal cancer, non-small cell lung cancer (NSCLC) or gastric cancer.
  3. The patients' TNM stage of NSCLC is IIIB-IV, colorectal cancer is IV, and gastric cancer is IV, in addition all of them should be with tumors that can not be radically resected.
  4. If patients have not received chemotherapy, they should be evaluated that tumor will not progress within 30 days, and their bodies can tolerate intravenous targeted therapy.
  5. Patients who meet the diagnostic criterion for cancer related fatigue with deficiency of qi and blood.
  6. The expected survival period is more than 3 months.
  7. Fatigue score evaluated by visual analogue fatigue scale isn't lower than 4, and Karnofsky scale score isn't lower than 60.
  8. Good compliance and agreeable to sign an informed consent before test.
  9. Subjects agree not to participate in other intervention studies during test.

Exclusion Criteria:

  1. Those who need immunotherapy or radiotherapy during the test.
  2. Those who have significant trauma injuries in the past one month.
  3. Those who have severe bleeding or systemic infection diseases that had not been completely controlled.
  4. Those who have tangible proofs of marrow or central nervous system metastasis.
  5. Those who have received erythropoietin or blood transfusion within 1 month before test.
  6. Those who have hypersplenism, hyperthyroidism, desmosis, tuberculosis and other diseases that have not been completely controlled.
  7. Those who complicated with serious diseases such as cardiovascular or cerebrovascular system diseases, active hepatitis, disfunction of liver or kidney.
  8. Those who are known or suspected to be allergic to test drugs.
  9. Those who have eaten EJiao products in the past 2 weeks.
  10. Those who have occurred Ileus.
  11. Those suffering from severe malabsorption or other diseases that affect gastrointestinal absorption.
  12. Those who cannot understand, read and fill in the self-rating scale due to their level of knowledge or intelligence.
  13. Those who may happen any unstable conditions or conditions that endanger the patient's safety or compliance, for example the spirits.
  14. Those who have been diagnosed with other malignant tumors (except fully treated cervix and skin carcinoma in situ, or other tumors that have been surgically cured and not recurred for at least 5 years) .
  15. Those who participated in other therapeutic clinical trials within 30 days.
  16. Pregnant or nursing women, or childbearing female that are inadequate contraception.
  17. Those who are inappropriate to participate in the study determined by investigators.

Sites / Locations

  • Oncology Department of Xiyuan hospital of China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

control group

Arm Description

Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles

Placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles

Outcomes

Primary Outcome Measures

Fatigue degree with the Piper fatigue scale (Piper)
Piper is composed of 24 questions assessing total CRF, as well as subscales of behavioral, affective, sensory, and cognitive/mood fatigue. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. Piper is taken at the baseline, 1 weeks, 3 weeks,4 weeks, and 6 weeks after treatment

Secondary Outcome Measures

The occurrence of myelosuppression during chemotherapy
1)the duration time of myelosuppression; 2) the proportion among them that should be intervened with salvage treatments; the salvage treatments, including their variety, quantity and duration times; 3) the incidence and duration time of grade 3-4 myelosuppression. Those measurements were recorded and calculated separately at the end of the study.
The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood
Those who are receiving chemotherapy should be measured at the baseline, 1 weeks, 3 weeks,4 weeks, 6 weeks and 10 weeks after treatment. Those who are not receiving chemotherapy should be measured at the baseline, 3 weeks, 6 weeks, 10 weeks.
Change of patients' living quality with the Edmonton symptom assessment scale(ESAS)
Changes of patients' living quality with ESAS to measure participants'responses to 11 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, feeling of well-being and pruritus). Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom"
Change of patients' functional status with Karnofsky performance status (KPS)
KPS Scores ranged from 100 to 0,The higher score represent the better health, the more likely that you are able to tolerate the side effects of treatment. It is generally considered that Karnofsky80 score or above represent patients can live independently, 60~80 score represent semi-independently, Under 60 represent patients often need help in living.
Quality of Life with Functional assessment of cancer therapy-fatigue（FACT-F）
FACT-F investigates participants from six dimensions (physiology, social/family status, emotion, function, fatigue, tumor) and each question is rated on a 5-point Likert scale. Higher scores represent more agreeable with the content of the items
Aldosterone, insulin-like growth factor, cortisol, growth hormone
Levels of serum hormone on aldosterone, insulin-like growth factor, cortisol, growth hormone
Change from baseline in lymphocyte subsets counts up to 6 Weeks: T Cell, B Cell, Natural Killer Cell (T,B,NK)
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells
Change from baseline in T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
T-Cell Cytokines
T-cell cytokine subsets include IFNγ, IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17A,IL-17F,IL-22,TNFα,TNFβ
Circulating metabolite concentrations by nontargeted metabolomics techniques
Blood concentrations of metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins
Triiodothyronine, free triiodothyronine, bound thyroxine, free thyroxine, thyroid stimulating hormone
Thyroid hormones index

Full Information

First Posted
September 1, 2019
Last Updated
February 21, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04147312
Brief Title
Fufang E'Jiao Jiang Intervening Cancer-related Fatigue
Acronym
FFEJJICRF
Official Title
The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Shandong 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
With the therapeutic tool of carcinoma increasing, life span extending, the solicitude for the patients'quality of life appear more important. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Our previous clinical experience have shown that traditional Chinese medicine（TCM） had a great effect on improving CRF, Several studies proven that its'mechanism were related to the regulation of immune function and endocrine hormones. Fufang E'Jiao Jiang (FFEJJICRF) is a commonly-used Chinese patent medicine and successfully marketed in China for many years, which are effective in improvement for TCM symptoms of deficiency with qi and blood. This proposal will investigate the effects of FFEJJICRF on CRF among non-small cell lung cancer, colorectal cancer, and gastric cancer, so as to find a new way for curing it in clinical.
Detailed Description
By conducting large sample, multicenter, double-blind, randomized comparison clinical research, this test will investigate the effects of fufang E'Jiao Jiang intervening cancer-related fatigue (CRF) with deficiency of qi and blood, under the guidance of its specification. This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators. And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of hormone, immune and metabonomics, so as to explore the advantages of traditional Chinese medicine（TCM） in the treatment of CRF and support some high quality, internationally recognized clinical evidence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue
Keywords
Traditional Chinese medicine, Fufang E'Jiao Jiang, Randomized controlled trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Intervention Type
Drug
Intervention Name(s)
Fufang E'Jiao Jiang
Other Intervention Name(s)
A listed Chinese Medicine
Intervention Description
Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Intervention Type
Drug
Intervention Name(s)
placebo containing low-dose fufang E'Jiao Jiang
Other Intervention Name(s)
placebo
Intervention Description
placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Primary Outcome Measure Information:
Title
Fatigue degree with the Piper fatigue scale (Piper)
Description
Piper is composed of 24 questions assessing total CRF, as well as subscales of behavioral, affective, sensory, and cognitive/mood fatigue. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. Piper is taken at the baseline, 1 weeks, 3 weeks,4 weeks, and 6 weeks after treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The occurrence of myelosuppression during chemotherapy
Description
1)the duration time of myelosuppression; 2) the proportion among them that should be intervened with salvage treatments; the salvage treatments, including their variety, quantity and duration times; 3) the incidence and duration time of grade 3-4 myelosuppression. Those measurements were recorded and calculated separately at the end of the study.
Time Frame
10 weeks
Title
The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood
Description
Those who are receiving chemotherapy should be measured at the baseline, 1 weeks, 3 weeks,4 weeks, 6 weeks and 10 weeks after treatment. Those who are not receiving chemotherapy should be measured at the baseline, 3 weeks, 6 weeks, 10 weeks.
Time Frame
10 weeks
Title
Change of patients' living quality with the Edmonton symptom assessment scale(ESAS)
Description
Changes of patients' living quality with ESAS to measure participants'responses to 11 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, feeling of well-being and pruritus). Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom"
Time Frame
10 weeks
Title
Change of patients' functional status with Karnofsky performance status (KPS)
Description
KPS Scores ranged from 100 to 0,The higher score represent the better health, the more likely that you are able to tolerate the side effects of treatment. It is generally considered that Karnofsky80 score or above represent patients can live independently, 60~80 score represent semi-independently, Under 60 represent patients often need help in living.
Time Frame
10 weeks
Title
Quality of Life with Functional assessment of cancer therapy-fatigue（FACT-F）
Description
FACT-F investigates participants from six dimensions (physiology, social/family status, emotion, function, fatigue, tumor) and each question is rated on a 5-point Likert scale. Higher scores represent more agreeable with the content of the items
Time Frame
6 weeks
Title
Aldosterone, insulin-like growth factor, cortisol, growth hormone
Description
Levels of serum hormone on aldosterone, insulin-like growth factor, cortisol, growth hormone
Time Frame
6 weeks
Title
Change from baseline in lymphocyte subsets counts up to 6 Weeks: T Cell, B Cell, Natural Killer Cell (T,B,NK)
Description
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells
Time Frame
6 weeks
Title
Change from baseline in T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
Description
T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
Time Frame
6 weeks
Title
T-Cell Cytokines
Description
T-cell cytokine subsets include IFNγ, IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17A,IL-17F,IL-22,TNFα,TNFβ
Time Frame
6 weeks
Title
Circulating metabolite concentrations by nontargeted metabolomics techniques
Description
Blood concentrations of metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins
Time Frame
6 weeks
Title
Triiodothyronine, free triiodothyronine, bound thyroxine, free thyroxine, thyroid stimulating hormone
Description
Thyroid hormones index
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively
Description
Safety evaluation
Time Frame
6 weeks
Title
Percentage of patients who dropout by other adverse reactions caused by drugs
Description
Another safety evaluation: Percentage of patients who dropout by other adverse reactions caused by drugs meanwhile excluding myelosuppression (grading standard of adverse reactions according to the evaluation standard of CTCAE v4.03)
Time Frame
6 weeks
Title
Collect costs of the whole observation period, and count the cost-effectiveness analysis based on the outcome of clinical study
Description
Evaluation of health economics
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age of patients between 18 and 75，gender not limited. Patients that pathologically diagnosed with colorectal cancer, non-small cell lung cancer (NSCLC) or gastric cancer. The patients' TNM stage of NSCLC is IIIB-IV, colorectal cancer is IV, and gastric cancer is IV, in addition all of them should be with tumors that can not be radically resected. If patients have not received chemotherapy, they should be evaluated that tumor will not progress within 30 days, and their bodies can tolerate intravenous targeted therapy. Patients who meet the diagnostic criterion for cancer related fatigue with deficiency of qi and blood. The expected survival period is more than 3 months. Fatigue score evaluated by visual analogue fatigue scale isn't lower than 4, and Karnofsky scale score isn't lower than 60. Good compliance and agreeable to sign an informed consent before test. Subjects agree not to participate in other intervention studies during test. Exclusion Criteria: Those who need immunotherapy or radiotherapy during the test. Those who have significant trauma injuries in the past one month. Those who have severe bleeding or systemic infection diseases that had not been completely controlled. Those who have tangible proofs of marrow or central nervous system metastasis. Those who have received erythropoietin or blood transfusion within 1 month before test. Those who have hypersplenism, hyperthyroidism, desmosis, tuberculosis and other diseases that have not been completely controlled. Those who complicated with serious diseases such as cardiovascular or cerebrovascular system diseases, active hepatitis, disfunction of liver or kidney. Those who are known or suspected to be allergic to test drugs. Those who have eaten EJiao products in the past 2 weeks. Those who have occurred Ileus. Those suffering from severe malabsorption or other diseases that affect gastrointestinal absorption. Those who cannot understand, read and fill in the self-rating scale due to their level of knowledge or intelligence. Those who may happen any unstable conditions or conditions that endanger the patient's safety or compliance, for example the spirits. Those who have been diagnosed with other malignant tumors (except fully treated cervix and skin carcinoma in situ, or other tumors that have been surgically cured and not recurred for at least 5 years) . Those who participated in other therapeutic clinical trials within 30 days. Pregnant or nursing women, or childbearing female that are inadequate contraception. Those who are inappropriate to participate in the study determined by investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xu yun, doctor
Phone
15210775378
Email
xyxiao78@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
cui ning, doctor
Phone
15652590697
Email
809918686@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xu yun, doctor
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xu, M.D.
Phone
8610 62835355
Email
xyxiao78@163.com
First Name & Middle Initial & Last Name & Degree
Yu Wu, M.D.
Phone
86 10 62835438
Email
wy713@vip.sina.com
First Name & Middle Initial & Last Name & Degree
zhuo song, doctoral student

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33834863
Citation
Song Z, Sun LY, Gu SS, Zhu XS, Lai HZ, Lu F, Cui N, Li QY, Wu Y, Xu Y. Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211002919. doi: 10.1177/15347354211002919.
Results Reference
derived

Learn more about this trial

Fufang E'Jiao Jiang Intervening Cancer-related Fatigue

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