Clinical trial NCT06515249: Integrative Therapies in Multiple Myeloma
Official title: Effectiveness and Safety of Integrative Therapies in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Integrative Medicine
Quality-of-life
Complementary medicine
Hematology
Acupuncture
Mind-body
Touch
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 study\&amp;#39;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 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

Primary outcomes:
measure: Quality-of-life specific to myeloma patients
timeFrame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
Secondary outcomes:
measure: General quality-of-life evaluation
timeFrame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
measure: Symptom relief
timeFrame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
measure: Compliance to conventional therapy
timeFrame: From enrollment to 1 year after enrollment
measure: Economic analysis
timeFrame: From enrollment to 3 months after enrollment
measure: Overall response rate (ORR) to myeloma treatment
timeFrame: From enrollment to 1 year after enrollment
measure: Progression-free survival (PFS)
timeFrame: From enrollment to 2 years after enrollment
measure: Overall survival (OS)
timeFrame: From enrollment to 2 years after enrollment
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center, Haifa, Israel
name: Ilana Levy Yurkovski, MD
role: PRINCIPAL_INVESTIGATOR
References: