Integrative Therapies in Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrative medicine.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness and Safety of Integrative Therapies in Multiple Myeloma
Overview
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 study\'s 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.
Interventions
- Other Integrative medicine
Integrative medicine treatments including acupuncture, touch, movement, mind-body, as patient\'s and staff\'s choice
Primary outcome measures
- Quality-of-life specific to myeloma patients [Time frame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group]
Secondary outcome measures (7)
- General quality-of-life evaluation [Time frame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group]
- Symptom relief [Time frame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group]
- Compliance to conventional therapy [Time frame: From enrollment to 1 year after enrollment]
- Economic analysis [Time frame: From enrollment to 3 months after enrollment]
- Overall response rate (ORR) to myeloma treatment [Time frame: From enrollment to 1 year after enrollment]
- Progression-free survival (PFS) [Time frame: From enrollment to 2 years after enrollment]
- Overall survival (OS) [Time frame: From enrollment to 2 years after enrollment]
Eligibility criteria
Inclusion criteria
- Age over 18
- Diagnosis of multiple myeloma
- Possibility to answer questionnaires once a month in Hebrew, Arabic or Russian
- Signing an informed consent form
Exclusion criteria
- Age under 18 years
- In patients who will receive acupuncture: platelet level below 20x10\^9/L
- In patients who will receive reflexology: deep vein thrombosis in the leg
- Hemodynamic instability
- Psychiatric disorder impairing competence
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Israel · 1 center
- Bnai Zion Medical Center — Haifa
Identifiers
NCT: NCT06515249 · 0054-24-BNZ