Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515249
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Integrative Therapies in Multiple Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Safety of Integrative Therapies in Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Multiple myeloma is a hematologic malignancy that can cause anemia renal failure bone disease and hypercalcemia Today myeloma is considered a chronic disease and most patients will receive ongoing biological treatments As a result this disease causes a number of symptoms related to the disease itself or its treatment which include among others weakness and fatigue bone or nerve pain depression and anxiety gastrointestinal symptoms impairment of sexual function etc These symptoms cause significant damage to quality-of-life which is similar in patients who receive different treatment lines As a result the FDA emphasized quality-of-life as a key outcome for the approval of new drugs for the disease
The conventional therapeutic approach to the various symptoms is based on supportive care guidelines including pharmacological and non-pharmacological treatment of pain gastrointestinal symptoms psychological components etc These treatments involve side effects and usually refer to individual symptoms
Complementary and integrative medicine includes treatments of touch movement mind-body acupuncture nutrition and nutritional supplements Many studies have shown the effectiveness of these treatments on various symptoms in cancer patients including pain depression and anxiety fatigue and weakness gastrointestinal symptoms etc In myeloma patients the effect of diet and nutritional supplements was mainly examined but there is also little information on the effectiveness of mind-body treatments on symptoms of anxiety and depression as well as acupuncture on neuropathy or on symptoms experienced by myeloma patients around autologous bone marrow transplantation
In recent years a wide variety of new drugs have entered the market that cause side effects that were unknown until now and little is known about the effect of complementary medicine treatments on symptoms and quality-of-life of myeloma patients since the development of these drugs
In this study we will examine the effect of complementary and integrative medicine treatments including acupuncture touch movement mind-body on the quality-of-life and symptoms that characterize myeloma patients during treatment with different lines of therapy including new drugs
Patients with a diagnosis of multiple myeloma who meet the studyamp39s inclusion criteria will be divided into the intervention group complementary medicine treatments and the control group no treatments according to their preferences All the patients of the intervention group and the patients of the control group who agree will be asked to fill out quality-of-life questionnaires validated and translated into Hebrew Arabic and Russian before the start of the treatment The questionnaires include European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30 which is a general quality-of-life questionnaire for cancer patients with the addition of MY20 which is an addition of 20 specific questions for patients with multiple myeloma the Edmonton Symptom Assessment System ESAS questionnaire which examines the severity of 10 common symptoms in patients with malignant disease and the EuroQol-5 Dimension EQ-5D questionnaire which examines quality-of-life in cancer patients and is used as a primary outcome in many clinical studies The same questionnaires will be sent again 1-2 weeks after the end of the treatments in the intervention group and 6-8 weeks after recruitment in the control group Socio-demographic and medical data will also be collected from the patients and their medical records
The conventional therapeutic approach to the various symptoms is based on supportive care guidelines including pharmacological and non-pharmacological treatment of pain gastrointestinal symptoms psychological components etc These treatments involve side effects and usually refer to individual symptoms
Complementary and integrative medicine includes treatments of touch movement mind-body acupuncture nutrition and nutritional supplements Many studies have shown the effectiveness of these treatments on various symptoms in cancer patients including pain depression and anxiety fatigue and weakness gastrointestinal symptoms etc In myeloma patients the effect of diet and nutritional supplements was mainly examined but there is also little information on the effectiveness of mind-body treatments on symptoms of anxiety and depression as well as acupuncture on neuropathy or on symptoms experienced by myeloma patients around autologous bone marrow transplantation
In recent years a wide variety of new drugs have entered the market that cause side effects that were unknown until now and little is known about the effect of complementary medicine treatments on symptoms and quality-of-life of myeloma patients since the development of these drugs
In this study we will examine the effect of complementary and integrative medicine treatments including acupuncture touch movement mind-body on the quality-of-life and symptoms that characterize myeloma patients during treatment with different lines of therapy including new drugs
Patients with a diagnosis of multiple myeloma who meet the studyamp39s inclusion criteria will be divided into the intervention group complementary medicine treatments and the control group no treatments according to their preferences All the patients of the intervention group and the patients of the control group who agree will be asked to fill out quality-of-life questionnaires validated and translated into Hebrew Arabic and Russian before the start of the treatment The questionnaires include European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30 which is a general quality-of-life questionnaire for cancer patients with the addition of MY20 which is an addition of 20 specific questions for patients with multiple myeloma the Edmonton Symptom Assessment System ESAS questionnaire which examines the severity of 10 common symptoms in patients with malignant disease and the EuroQol-5 Dimension EQ-5D questionnaire which examines quality-of-life in cancer patients and is used as a primary outcome in many clinical studies The same questionnaires will be sent again 1-2 weeks after the end of the treatments in the intervention group and 6-8 weeks after recruitment in the control group Socio-demographic and medical data will also be collected from the patients and their medical records
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