Integrative Therapies in Multiple Myeloma

NCT ID: NCT06515249

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2028-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Integrative medicine

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

Group Type: EXPERIMENTAL

Integrative medicine

Intervention Type: OTHER

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrative medicine

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilana Levy Yurkovski, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center, Haifa, Israel

Locations

Bnai Zion Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilana Levy Yurkovski, MD

Role: CONTACT

ilana.levy@b-zion.org.il

+972525086128

Facility Contacts

Miriam Goldberg

Role: primary

miriam.goldberg@b-zion.org.il

972-48359351

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0054-24-BNZ

Identifier Type: -

Identifier Source: org_study_id