RecruitingNot ApplicableNCT06515249

Integrative Therapies in Multiple Myeloma

Effectiveness and Safety of Integrative Therapies in Multiple Myeloma


Sponsor

Bnai Zion Medical Center

Enrollment

300 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing integrative (complementary) therapies — including acupuncture, reflexology, and other supportive approaches — to see if they can improve quality of life, reduce fatigue, and ease treatment side effects in people with multiple myeloma. **You may be eligible if...** - You are over 18 years old - You have a diagnosis of multiple myeloma - You are able to fill out monthly questionnaires in Hebrew, Arabic, or Russian - You have signed an informed consent form **You may NOT be eligible if...** - You are under 18 - For acupuncture: your platelet count is below 20 x 10^9/L - For reflexology: you have deep vein thrombosis (blood clot) in your leg - You have hemodynamic instability (unstable blood pressure/circulation) - You have a psychiatric disorder affecting your ability to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntegrative medicine

Integrative medicine treatments including acupuncture, touch, movement, mind-body, as patient\'s and staff\'s choice


Locations(1)

Bnai Zion Medical Center

Haifa, Israel

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NCT06515249


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