RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2024-06-30

Brief Summary

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This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.

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Detailed Description

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In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.

Conditions

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Cancer-related Problem/Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TCM decoction

Compound granules of Traditional Chinese Medicine

Group Type EXPERIMENTAL

TCM Formula

Intervention Type DRUG

TCM herbs：White peony 10g, angelica 10g, Astragalus 20g, Atractylodes macrocephala 10g, tangerine peel 6g, Poria cocos 10g, raw land 10g, cinnamon 3g, Polygala tenuifolia 6g, Schisandra chinensis 6g, raw licorice 6g.

placebo

Placebo only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs

Interventions

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TCM Formula

TCM herbs：White peony 10g, angelica 10g, Astragalus 20g, Atractylodes macrocephala 10g, tangerine peel 6g, Poria cocos 10g, raw land 10g, cinnamon 3g, Polygala tenuifolia 6g, Schisandra chinensis 6g, raw licorice 6g.

Intervention Type DRUG

Placebo

Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs

Intervention Type DRUG

Other Intervention Names

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RSYR decoction Placebo dicoction

Eligibility Criteria

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Inclusion Criteria

* Malignant tumor patients with pathological diagnosis
* Men and women aged 18-75
* KPS score ≥ 70, expected survival time more than 6 months
* The function of heart, lung, liver and kidney was normal
* Hemoglobin ≥ 8g
* Neuroendocrine function is normal
* BMI ≥ 18.5.
* Cancer pain, VAS score \< 3
* Fatigue score ≥ 4
* syndrome differentiation is deficiency of Qi and blood