High-grade LymphomaPhase 3NCT06510530
Astragalus for Symptomatic Alleviation in High-grade Lymphoma
A Phase 3 study testing Astragalus in people with High-grade Lymphoma, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-grade Lymphoma
- What is being tested?
- Astragalus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2027to Aug 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Astragalus for Symptomatic Alleviation in Patients With High-grade Lymphoma Treated With Chemotherapy: a Double-blind Randomized Placebo-controlled Trial
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.
Read more
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.
- Conditions
- High-grade Lymphoma
- Being tested
- Astragalus, Placebo
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstragalusDietary supplement
Patients in the intervention group will receive capsules of the Astragalus plant (scientific name: Astragalus membranaceus, common name: Huang Qi) at an initial dose of 2 grams (4 capsules) per day with the option of increasing the dose to 4 grams (8 capsules) per day according to researchers' assessment and patient tolerance. The dose was determined by a focus group of 5 herbalists and according to data from the literature on oncology patients. The duration of the treatment will be up to a month from the end of the chemotherapy treatment which usually lasts up to six months.
PlaceboDietary supplement
Placebo capsules that look similar to Astragalus capsules will be given to patients from the control group, between 4 and 8 capsules per day according to the researcher's assessment and tolerability. The duration of the treatment will be up to a month from the end of the chemotherapy treatment which usually lasts up to six months.
| Study group | Role | What they receive |
|---|---|---|
| Astragalus | Experimental | Not described Receives: Dietary Supplement: Astragalus |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-of-life
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.
Measured: From baseline to end-of-treatment, up to 6 months
Secondary outcomes (2)
Symptoms
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).
Measured: From baseline to end-of-treatment, up to 6 months
Fatigue
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.
Measured: From baseline to end-of-treatment, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startAug 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilana Levy Yurkovski, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510530
- Sponsor's protocol ID
- BNZ-0036-24
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Astragalus for Symptomatic Alleviation in Patients With High-grade Lymphoma Treated With Chemotherapy: a Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06510530
- Acronym / sponsor ID
- BNZ-0036-24
- Conditions
- High-grade Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Aug 2027 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astragalus | Experimental | Dietary Supplement: Astragalus |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstragalusPatients in the intervention group will receive capsules of the Astragalus plant (scientific name: Astragalus membranaceus, common name: Huang Qi) at an initial dose of 2 grams (4 capsules) per day with the option of increasing the dose to 4 grams (8 capsules) per day according to researchers' assessment and patient tolerance. The dose was determined by a focus group of 5 herbalists and according to data from the literature on oncology patients. The duration of the treatment will be up to a month from the end of the chemotherapy treatment which usually lasts up to six months. | Dietary supplement | Astragalus |
| PlaceboPlacebo capsules that look similar to Astragalus capsules will be given to patients from the control group, between 4 and 8 capsules per day according to the researcher's assessment and tolerability. The duration of the treatment will be up to a month from the end of the chemotherapy treatment which usually lasts up to six months. | Dietary supplement | Placebo |
Primary outcome
Quality-of-life
Time frame: 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.
2 secondary outcomes
Symptoms
Time frame: From baseline to end-of-treatment, up to 6 months
Fatigue
Time frame: From baseline to end-of-treatment, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilana Levy Yurkovski, MD principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Astragalus in people with High-grade Lymphoma, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilana Levy Yurkovski, MD (0525086128 ext. 972, ilana.e.levy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-of-life (time frame: From baseline to end-of-treatment, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.