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LymphomaNCT05982223

Integrative Medicine in Lymphoma Survivors

A study testing Acupuncture, Mind-body therapy and Touch therapy in people with Lymphoma, run by Bnai Zion Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Acupuncture, Mind-body therapy and Touch therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteIsrael
Study dates
13 Jul 2023to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Israel1 site, 1 recruiting
  • Bnai Zion Medical Center

    Haifa, 3339419

    Ilana Levy Yurkovski, MD, 972-525086128, ilana.levy@b-zion.org.il

    Ilana Levy Yurkovski, MD

    Recruiting

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Conditions
Lymphoma
Being tested
Acupuncture, Mind-body therapy, Touch therapy, Movement therapy, Herbal supplements
Keywords
Lymphoma survivors, Integrative medicine, Complementary medicine, Quality of life, Shiatsu, Acupuncture, Hematology
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    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.

  • Mind-body therapyProcedure or surgery

    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.

  • Touch therapyProcedure or surgery

    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.

  • Movement therapyProcedure or surgery

    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.

  • Herbal supplementsDietary supplement

    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.

  • Emotional treatmentBehavioural

    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.

Study groups in NCT05982223
Study groupRoleWhat they receive
Integrative oncologyExperimentalAll 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.
Receives: Procedure: Acupuncture; Procedure: Mind-body therapy; Procedure: Touch therapy; Procedure: Movement therapy; Dietary Supplement: Herbal supplements; Behavioral: Emotional treatment
Conventional medicine onlyNo interventionAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality-of-life by EQ-5D scale

    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.

    Measured: Through study completion: an average of 1 year

Secondary outcomes (8)
  1. Symptom relief

    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

    Measured: Through study completion: an average of 1 year

  2. Cognitive functions

    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.

    Measured: Through study completion: an average of 1 year

  3. Perception of disease control

    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)

    Measured: Through study completion: an average of 1 year

  4. Economic evaluation

    Questionnaire on the measurement, valuation, and estimation of costs adapted from a validated questionnaire on informal care

    Measured: Through study completion: an average of 1 year

  5. Adverse events

    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.

    Measured: Through study completion: an average of 1 year

  6. Relapse of lymphoma

    Based on clinical evaluation of the physician

    Measured: 3 years

  7. Progression-free survival

    Time from screening to the occurrence of disease progression or death, based on clinical evaluation

    Measured: 3 years

  8. Overall survival

    Time from screening to death, based on clinical evaluation

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start13 Jul 2023
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Preference-based comparative effectiveness clinical trial
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982223
Sponsor's protocol ID
0050-23-BNZ
Status last verified
Sep 2026
First submitted
16 Jul 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture, Mind-body therapy and Touch therapy in people with Lymphoma, run by Bnai Zion Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dana Weizer (972-543295952, dana.weizer@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality-of-life by EQ-5D scale (time frame: Through study completion: an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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