Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510530
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-30
Brief Title:
Astragalus for Symptomatic Alleviation in High-grade Lymphoma
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nauseavomiting 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 1843 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 3236 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
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 1843 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 3236 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None