Integrative Therapies in Multiple Myeloma

NCT06515249 | Recruiting DMC

• 1 other identifier: 0054-24-BNZ
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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\'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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Integrative Medicine; Quality-of-life; Complementary medicine; Hematology; Acupuncture; Mind-body; Touch

Outcome Measures

Primary Outcomes (1)

• Quality-of-life specific to myeloma patients

  EORTC QLQ-MY2 (European Organization for the Research and Treatment of Cancer Quality of Life for Myeloma patients) score at 1-2 weeks after end-of-treatment in intervention group and 7-8 weeks after recruitment in control group. It comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. Domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

  From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

Secondary Outcomes (7)

• General quality-of-life evaluation

  From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

• Symptom relief

  From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

• Compliance to conventional therapy

  From enrollment to 1 year after enrollment

• Economic analysis

  From enrollment to 3 months after enrollment

• Overall response rate (ORR) to myeloma treatment

  From enrollment to 1 year after enrollment

Study Arms (2)

Integrative medicine

EXPERIMENTAL

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

Other: Integrative medicine

Control

NO INTERVENTION

Interventions

Integrative medicine OTHER

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

Integrative medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Diagnosis of multiple myeloma
• Possibility to answer questionnaires once a month in Hebrew, Arabic or Russian
• Signing an informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3339419, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ilana Levy Yurkovski, MD

  Bnai Zion Medical Center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilana Levy Yurkovski, MD

CONTACT

+972525086128; ilana.levy@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 23, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)