Astragalus for Symptomatic Alleviation in High-grade Lymphoma

Phase 3

Not yet recruiting

• Conditions: High-grade Lymphoma
• Interventions: Dietary Supplement: Astragalus; Dietary Supplement: Placebo

• Registration Number: NCT06510530
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

Lymphoma is a malignant disease of the lymph nodes. There are different types of lymphoma: when some of the lymphomas are indolent and require only follow-up, in cases of aggressive lymphoma or indolent lymphoma with a burden of disease, treatment is necessary, which usually includes chemotherapy with or without biological drugs. These drugs often cause significant damage to the quality of life, various symptoms including exhaustion, neuropathic pain, nausea/vomiting, cognitive decline, as well as a drop in blood counts with serious life-threatening infections that cause a delay in the treatment date that may affect the prognosis.

Drug treatments for symptomatic relief and improvement in quality of life in patients with lymphoma are missing, with only a partial effect and involving side effects.

Astragalus (scientific name: Astragalus membranaceus, common name: Huang Qi) is a perennial flowering plant common in China with a long history of use in traditional Chinese medicine. It is given in various forms of root in combination with other herbs, medicinal soups and as tablets, capsules, solutions, ointments for local use, or subcutaneous or intravenous injection. In patients with oncological diseases, a systematic review (4 trials on a total of 342 patients) showed an improvement in nausea and vomiting as well as in the immune system in patients with colon cancer who received Chemotherapy. A meta-analysis of 27 studies on 1,843 patients with colon cancer also demonstrated a reduction in chemotherapy-induced nausea in patients who received a combination of astragalus with chemotherapy compared to chemotherapy alone. In another meta-analysis that included 45 trials on 3,236 patients with liver cancer, an improvement in 12-month survival was reported with products containing astragalus. In a randomized study of 136 patients with lung cancer, three treatment cycles with astragalus by injection in combination with chemotherapy (vinorelbine and cisplatin) resulted in a significant improvement in quality of life compared to the control group that received chemotherapy alone. Similar results found in 23 patients with metastatic malignancy receiving astragalus by injection in combination with chemotherapy. In addition, a study on 90 patients with advanced cancer showed an improvement in fatigue in patients who received astragalus. Also, a pilot study on 60 patients with breast cancer showed that intravenous administration of astragalus improved blood counts in patients who received it in combination with chemotherapy compared to chemotherapy alone. In patients with hematological malignancies, a study was conducted on 498 patients with acute myeloid leukemia and showed that the use of astragalus or plants containing astragalus was associated with improved survival compared to patients who did not receive it. In the context of lymphoma, a pharmacological study in vivo on animals with lymphoma showed that a combination of an astragalus-containing formula with adriamycin-type chemotherapy improved the effect of adriamycin for the treatment of B-cell lymphoma. Another study in patients who had completed conventional chemotherapy with Rituximab Cyclophosphamide Adriamycine Vincristine Prednisone (R-CHOP) for diffuse large B-cell lymphoma showed that administration of a formula containing astragalus improved immune function and blood counts. Finally, a randomized placebo-controlled study showed that giving a formula containing astragalus to patients under R-CHOP chemo-immunotherapy as first line for diffuse large B cell lymphoma high risk significantly reduced the appearance of side effects from the treatment and improved response to the treatment chemotherapy compared to the control group.

Side effects attributed to astragalus include fatigue, weakness, headaches and hypotension, but in the cited studies and meta-analyses, no increase in the rate of side effects was found in the groups of patients who received this plant compared to the control groups, and no safety problems were described in the use of astragalus in combination with chemotherapy.

In light of the multitude of symptoms that affect the quality of life and adherence to treatment in patients with lymphoma receiving chemotherapy, and in light of the encouraging findings in the literature about symptomatic improvement as a result of combining astragalus during chemotherapy in various malignancies, the investigators aim to examine the effectiveness and safety of astragalus during the treatment of patients with high-grade lymphoma on symptomatic relief and adherence to chemotherapy in a randomized, double-blind, placebo-controlled study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-30
• Study First Submitted QC: 2024-07-14
• Last Update Submitted: 2024-07-14
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Study Start: 2024-08
• Primary Completion: 2030-08
• Study Completion: 2032-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age over 18
• Diagnosis of high-grade lymphoma
• Need to start treatment for lymphoma that includes chemotherapy as first line
• Possibility to answer questionnaires once a month
• Signing an informed consent form

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Exclusion Criteria

• Taking up to a week before the randomization a drug with the potential for an interaction of major clinical significance with Astragalus according to a professional database
• Administration of chemotherapy in the past
• Significant disturbance in liver enzymes: Aspartate transaminase and/or alanine transaminase above 5 times the upper limit of normal
• Significant renal dysfunction: glomerular filtration rate under 30 ml/min according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• Active autoimmune disease
• Pregnancy or breastfeeding
• Active participation in another interventional study
• Psychiatric disorder with impaired cognitive qualifications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Astragalus	Astragalus	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Quality-of-life	From baseline to end-of-treatment, up to 6 months	European Organization Research for Treatment of cancer core quality of life (EORTC-QLQ-C30) questionnaire summary score which is calculated from the mean of 13 of the 15 quality-of-life (QLQ-C30) scales of the questionnaire = (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ 100-Fatigue+ 100-Pain+ 100-Nausea_Vomiting+ 100-Dyspnoea+ 100-Sleeping Disturbances+ 100-Appetite Loss+ 100-Constipation+ 100-Diarrhoea)/13. Scores range from minimum 0 to maximum 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Secondary Outcome Measures

Name	Time	Method
Symptoms	From baseline to end-of-treatment, up to 6 months	Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire at end of treatment: two main concerns of the patient which are rated for severity using a simple numerical Likert scale 0-6 (0: not concerning at all; 6: very concerning).
Fatigue	From baseline to end-of-treatment, up to 6 months	European Organization Research for Treatment of cancer core quality of life (EORTC-QLQ-C30) questionnaire fatigue score. Scores range from minimum 0 to maximum 100; a higher score represents a higher ("worse") level of fatigue.

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel