Integrative Medicine in Lymphoma Survivors

July 30, 2023 updated by: Bnai Zion Medical Center

Effectiveness of Integrative Medicine Treatments in Lymphoma Survivors

Lymphoma is a cancer of the lymph nodes. While some are "silent" and only require follow-up, in cases of aggressive lymphoma, treatment is necessary, and usually includes biological drugs, chemotherapy or both. These drugs often cause significant damage to quality-of-life and various symptoms that do not always go away. Although the treatments are often limited in time and with recovery rates over 60%, most patients are left with a significantly impaired quality-of-life and difficulty in returning to their previous life. Many studies, most of which were conducted in breast cancer survivors, show the place of complementary medicine in the recovery process, both in terms of symptom relief and in improving quality-of-life. Few studies have examined the place of complementary and integrative medicine in lymphoma survivors. The purpose of the present study is to examine the effect of integrative treatments (a combination of conventional and complementary medicine) on quality-of-life of lymphoma survivors, on specific symptoms caused by the disease and its treatment, on economic and social aspects, as well as on the course of the disease. At the hematological unit of Bnai Zion Medical Center, Haifa, Israel, patients with lymphoma who have received chemotherapy, biological treatment or both, and have been defined as recovering by the treating hematologist, will be offered a choice of different types of complementary medicine (acupuncture, herbal medicine, mind-body, movement and touch therapies), emotional treatment (conversations with social worker, spiritual guidance), or both, in addition to the medical and nursing care offered to all survivors. Patients who prefer not to come to the clinic for these treatments will be assigned to the control group and will fill out questionnaires only. The duration of the treatments will be six months and follow-up for another two years. The type of treatments the patient will receive will be chosen in coordination between the integrative team and the patient and according to the symptoms. An assessment will be made on the effect of these treatments on quality-of-life of lymphoma survivors (based on questionnaires), including physical, psycho-spiritual and economic aspects, as well as on the course of the disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Lymphoma is a malignant disease of the lymph nodes. While some of the lymphomas are indolent and require only follow-up, in cases of aggressive lymphoma or indolent lymphoma with a high burden of disease, treatment is necessary and usually includes biological drugs, chemotherapy or both. These drugs often cause significant damage to quality-of-life, including various symptoms such as fatigue, gastrointestinal symptoms, neuropathy, as well as psycho-emotional and financial damage surrounding the cessation of work during the treatments. Although the treatments are often limited in time and with recovery rates above 60% in the case of aggressive lymphoma, most patients are left with a significant impairment in the quality-of-life and difficulty in returning to the life before the disease. Survivor clinics are usually located outside the oncology clinics and are designed to help cancer patients return to life after they have recovered from the disease. Many studies, mostly in breast cancer survivors, show the place of complementary medicine in the recovery process, both in terms of relieving symptoms and improving quality-of-life. Few studies have examined the place of complementary medicine in survivor clinics in haemato-oncological patients after intensive and time-limited treatments. In addition, integrative oncology that incorporates both conventional and complementary medicine, is a developing discipline that has been shown to be effective in the relief of many cancer-related symptoms such as chemotherapy-induced peripheral neuropathy, which is common in lymphoma survivors, and other outcomes such as quality-of-life, or even survival.

Hypothesis: In the present study, we assumed that an integrative oncology approach was effective for improving different outcomes of lymphoma survivors including quality-of-life, specific symptoms caused by the disease and its treatment, economic and social aspects, as well as the course of the disease.

Study plan: At the Hematology Unit at Bnai Zion Hospital, adult lymphoma survivors that received chemotherapy, biologic therapy or both during active lymphoma treatment, and are willing to participate in the study, will be recruited up to one year after remission. After completing questionnaires and an initial assessment by the integrative team, the patients will be divided by preference between the control group who will receive the mandatory basic treatment for follow-up after the disease (medical and nursing); and the intervention group who will come to the clinic and receive, in addition to the above, emotional treatments (counseling, spiritual guidance), complementary medicine (acupuncture, herbal supplements, mind-body, touch and/or movement therapies) or both. The type and frequency of complementary therapy will be chosen by the integrative team in coordination with the patient, based on patient's symptoms and preferences. The duration of the intervention will be 6 months from recruitment. During follow-up, the patients will fill-out a MYCAW questionnaire to assess symptoms in each treatment (or once a month in the control group) and a safety assessment will be performed using the validated Acupuncture-Adverse Events (Acup-AE) questionnaire for acupuncture or targeted questioning for other treatments. Also, the patients will fill-out quality-of-life questionnaires once a month and economic and cognitive evaluation questionnaires once every 3 months. The haemato-oncologist will complete an assessment of the disease state once every 3 months. In addition, 3 months after the end of the treatments, the patients will fill-out all the same questionnaires for follow-up. The haemato-oncologist will perform a medical follow-up on the condition of the disease once every 3 months for two years from the end of the treatments at the survivor clinic.

The primary outcome is the effect of an integrative approach on quality-of-life of lymphoma survivors. Secondary outcomes include the effect of such approach on specific symptoms caused by the disease and its treatment, economic and social aspects, as well as on the course of the disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Haifa, Israel, 3339419
        • Recruiting
        • Bnai Zion Medical Center
        • Principal Investigator:
          • Ilana Levy Yurkovski, MD
        • Sub-Investigator:
          • Ohad Cohen Naznin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with a lymphoproliferative disease
  • Aged 18 years or older
  • Received chemotherapy, biological treatment or both for treating the lymphoproliferative disease
  • Defined in remission for less than one year by the haemato-oncologist (maintenance therapy is authorized)
  • Can respond to questionnaires
  • Signed informed consent

Exclusion Criteria: None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Integrative oncology
All patients will be followed up by a haemato-oncologist. The frequency and type of visits and exams will be determined by National Comprehensive Cancer Network (NCCN) guidelines, patients' symptoms and physician's clinical judgement. Patients recruited to the intervention arm will receive, on top of the defined conventional medicine follow-up, integrative oncology intervention including emotional treatments (counseling, spiritual guidance), complementary medicine (acupuncture, herbal supplements, mind-body, touch and/or movement therapies) or both. The type and frequency of these interventions will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
Procedure: Acupuncture
The frequency of acupuncture will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
Procedure: Mind-body therapy
The frequency of mind-body therapy (hypnosis, guided imagery) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
Procedure: Touch therapy
The frequency of touch therapy (shiatsu, reflexology) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
Procedure: Movement therapy
The frequency of movement therapy (Tai-Chi, Qi-Qong) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
Dietary supplement: Herbal supplements
The choice of herbal supplement will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
Behavioral: Emotional treatment
The frequency of emotional treatments (counseling, spiritual guidance) will be defined by the integrative team in coordination with the patient, based on evidence-based data, patient's symptoms, and preferences. The duration of the intervention will be 6 months from recruitment.
No Intervention: Conventional medicine only
All patients will be followed up by a haemato-oncologist. The frequency and type of visits and exams will be determined by NCCN guidelines, patients' symptoms and physician's clinical judgement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality-of-life by EQ-5D scale
Time Frame: Through study completion: an average of 1 year
EQ-5D scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Through study completion: an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom relief
Time Frame: Through study completion: an average of 1 year
Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing
Through study completion: an average of 1 year
Cognitive functions
Time Frame: Through study completion: an average of 1 year
Functional Assessment of Cancer Therapy - cognitive (FACT-cog) questionnaire: evaluates perceived cognitive functioning and their impact on quality of life. This is a self-reported 37-item questionnaire that consists of four subscales: Perceived Cognitive Impairment (CogPCI) (20 items), Perceived Cognitive Ability (CogPCA) (9 items), Comments from Others on Cognitive Function (Cog-Oth) (4 items), and Impact on Quality of Life (Cog-QoL) (4 items). All items are rated for the previous week, including the day of administration, on a 5-point Likert scale ranging from 0 "Never" or "Not at all" to 4 "Several times a day" or "Very much". The total CogPCI subscale ranges from 0 to 72, the CogPCA ranges between 0 and 28, and each of the Cog-QoL and Cog-Oth ranges between 0 and 16. The total score for the FACT-Cog is computed by summing all the item scores and ranges from 0 to 148 points, with a higher score indicative of better perceived cognitive functioning.
Through study completion: an average of 1 year
Perception of disease control
Time Frame: Through study completion: an average of 1 year
Perceived Personal Control (PPC) scale: a 4-questions-scale, with each question evaluating in a 0-4 scale the perception of disease control (0: worse control to 4: best control)
Through study completion: an average of 1 year
Economic evaluation
Time Frame: Through study completion: an average of 1 year
Questionnaire on the measurement, valuation, and estimation of costs adapted from a validated questionnaire on informal care
Through study completion: an average of 1 year
Adverse events
Time Frame: Through study completion: an average of 1 year
A checklist with acupuncture adverse events based on the Acupuncture-Adverse Events (AcupAE) questionnaire will be used to evaluate acupuncture-associated safety events after each treatment. For non-acupuncture complementary medicine therapies, the practitioner will directly question and evaluate the patient after each intervention for possible safety events. Specifically for dietary and herbal supplements, adverse events and interactions will be evaluated at each visit, and the Naranjo and adapted Drug Interaction Probability Scales (DIPS) will be used to assess the causality of such events with the specific dietary supplements.
Through study completion: an average of 1 year
Relapse of lymphoma
Time Frame: 3 years
Based on clinical evaluation of the physician
3 years
Progression-free survival
Time Frame: 3 years
Time from screening to the occurrence of disease progression or death, based on clinical evaluation
3 years
Overall survival
Time Frame: 3 years
Time from screening to death, based on clinical evaluation
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bnai Zion Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ilana Levy Yurkovski, MD, Bnai Zion Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0050-23-BNZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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