CancerNCT05833165
Feasibility of Integrating Homeopathic Approach in a Comprehensive Cancer Center
An observational study of Cancer and Quality of Life, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Quality of Life, Complementary Medicine
- What is being tested?
- Feasibility of a supportive approach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2023to 1 Jan 2028
- Phase
- Observational
- 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
Study population: Patients that elect to use complementary and integrative medicine during cancer care and make a choice to use homeopathy as part of this use
Who may be able to join
- • 18 years of age or older
- Ability to read, write, and understand the Hebrew language
- Patients treated at the Division of Oncology in Rambam Health Campus.
- Performance status of ECOG 0-2.
- Consent to participate in the study.
Who cannot join
- • Inability to understand the intent of the study and follow the instructions
- Diagnosis of active psychosis, altered mental state or severe cognitive impairment confirmed by the patient's attending physician.
- Frailty, ECOG worse than 2, or other unstable medical conditions as confirmed by the patient's attending physician including acute illness, fever, unclear rash or medical conditions that would preclude participation in an interview session lasting 15-30 minutes
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
- Recruiting
Rambam Medical Center
Haifa, 30900
Moshe Frenkel, MD, 0523311255, frenkelm@netvision.net.il
About this study
Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer. Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. In many countries, homeopathy is being one the CIM methods integrated with a general sense that this treatment is beneficial to the well-being and quality of life (QoL) of cancer patients. In this observational study we will evaluate the feasibility of integrating homeopathic approach in patients attending the complementary and integrative oncology service at the division of oncology in Rambam Health Campus in Haifa, Israel, a major referral comprehensive cancer center.
This observational study will evaluate three main ingredients of acceptance:
- Obtaining the reasons that patients willing to integrate this supportive approach
- Patient acceptance of this supportive approach as well as compliance with the homeopathic approach
- Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters.
Read the detailed description
Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer.
Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. As a response to this demand, there is an understanding that these approaches need to be integrated in cancer care. In 90% of large comprehensive cancer centers in the US and in many others in Europe and elsewhere, complementary and integrative medicine is being integrated into supportive patient care.
In Israel similar trend is observed and 8 integrative oncology services has been established around the country in the majority of oncology centers. Homeopathy is one of the CIM modalities utilized by patients with cancer. It is widely practiced worldwide, especially in Europe, Asia, and Latin America.
In the United States, during the 1990s, sales of homeopathic medicines grew at an annual rate of 20-25%, and in the 2015 US National health statistics report, homeopathy was mentioned as used by over 5 million people.
This modality involves detailed interview that emphasizes the unique characteristics of symptoms experienced by patients followed by utilizing highly diluted substances. Dilutions that are above 12c (dilution of 10-24 actually do not have the original substance), which are commonly used in homeopathy, reflect that the original material is not in this remedy. As a result of this understanding this complementary therapy remains one of the debated modalities in CIM.
Some mention that patients seek that method of care due to the fact that this approach emphasizes empathic listening to patients' concerns and worries, and the effect of the actual remedy, due to its high dilution, reflect a placebo response.
On the other hand, some clinical studies reveal that the use of homeopathy in cancer care, as a supportive approach, reflects clinical benefit that is not attributed to placebo, without risk of side effects or interactions with the conventional oncology approach.
In one prospective observational study done in Germany with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (n = 259), and one cohort with conventionally treated cancer patients (n = 380). It was observed that an improvement in quality of life was observed in patients taking the addition of homeopathic treatment, as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.
Another recent descriptive study that was conducted in France in three oncology centers in one city. Researchers observed that homeopathy was used in 30% of the cancer patients. (n=633) The homeopathy was used as an additional supportive measure. Fatigue was one of the leading symptoms that improved in 80% of the patients that homeopathy was added to their care.
An Israeli study evaluated the adherence to homeopathic treatment among cancer patients who received a CIM consultation (n=124). The authors found that homeopathy treatment was feasible, with two-thirds of patients acquiring and self-administering the remedies as prescribed. Fatigue was one of the main symptoms that patients felt that improved with the addition of homeopathy.
In another prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter, phase III study at the University of Vienna, researchers evaluated the possible effects of additive homeopathic treatment compared with placebo in 150 patients with stage IV Non-Small Cell Lung Cancer (NSCLC). Researchers found that there was a significant improvement of quality of life measures in the additive homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment. In addition, median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as, versus control (228 days; p < .001).
Homeopathy is considered safe and without adverse effects, neither direct (i.e., toxic effects) nor indirect (i.e., interactions with conventional anticancer agents).
In this study, patients affected by cancer that attend the oncology department in Rambam Health Campus, and wish to utilize the CIM service, will be offered this option of care.
The aim of the present study is therefore to evaluate the feasibility of the process of integrating homeopathy as a potential treatment option for symptom control and improvement in quality of life in cancer patients, in a comprehensive cancer center.
This observational study will evaluate three main ingredients:
- Obtaining main concerns of patients that agree to utilize this method
- Patient acceptance of this supportive approach that will be reflected in obtaining and self-administering the remedies as prescribed.
- Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters, at the initial evaluation, and during follow up visits.
- Conditions
- Cancer, Quality of Life, Complementary Medicine, Integrative Medicine
- Being tested
- Feasibility of a supportive approach
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of a supportive approachBehavioural
Evaluating reasons for patients to use the approach
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of a supportive approach | Evaluating a feasibility of an approach Receives: Behavioral: Feasibility of a supportive approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a supportive approach
Questionnaire
Measured: 6-12 weeks
Quality of life- Level of Distress
Distress thermometer
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOSHE FRENKEL MD, Rambam Health Care Campus
- Investigators
- Maria Suleymanov, RN, Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833165
- Sponsor's protocol ID
- RMB-0194-22
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Theunissen I, Bagot JL. Supportive cancer care: is integrative oncology the future? Curr Opin Oncol. 2024 Jul 1;36(4):248-252. doi: 10.1097/CCO.0000000000001027. Epub 2024 Feb 23.
PubMed 38842016Frenkel M. Is There a Role for Homeopathy in Cancer Care? Questions and Challenges. Curr Oncol Rep. 2015 Sep;17(9):43. doi: 10.1007/s11912-015-0467-8.
PubMed 26210222Frass M, Lechleitner P, Grundling C, Pirker C, Grasmuk-Siegl E, Domayer J, Hochmair M, Gaertner K, Duscheck C, Muchitsch I, Marosi C, Schumacher M, Zochbauer-Muller S, Manchanda RK, Schrott A, Burghuber O. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study. Oncologist. 2020 Dec;25(12):e1930-e1955. doi: 10.1002/onco.13548. Epub 2020 Nov 7.
PubMed 33010094Dolev T, Ben-David M, Shahadi I, Freed Y, Zubedat S, Aga-Mizrachi S, Brand Z, Galper S, Jacobson G, Avital A. Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019470. doi: 10.1177/15347354211019470.
PubMed 34027702Samuels N, Freed Y, Weitzen R, Ben-David M, Maimon Y, Eliyahu U, Berger R. Feasibility of Homeopathic Treatment for Symptom Reduction in an Integrative Oncology Service. Integr Cancer Ther. 2018 Jun;17(2):486-492. doi: 10.1177/1534735417736133. Epub 2017 Nov 2.
PubMed 29094627
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Integrating Homeopathic Approach in a Comprehensive Cancer Center
- ClinicalTrials.gov ID
- NCT05833165
- Acronym / sponsor ID
- RMB-0194-22
- Conditions
- Cancer, Quality of Life, Complementary Medicine, Integrative Medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer. Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. In many countries, homeopathy is being one the CIM methods integrated with a general sense that this treatment is beneficial to the well-being and quality of life (QoL) of cancer patients. In this observational study we will evaluate the feasibility of integrating homeopathic approach in patients attending the complementary and integrative oncology service at the division of oncology in Rambam Health Campus in Haifa, Israel, a major referral comprehensive cancer center.
This observational study will evaluate three main ingredients of acceptance:
- Obtaining the reasons that patients willing to integrate this supportive approach
- Patient acceptance of this supportive approach as well as compliance with the homeopathic approach
- Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters.
Detailed description
Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer.
Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. As a response to this demand, there is an understanding that these approaches need to be integrated in cancer care. In 90% of large comprehensive cancer centers in the US and in many others in Europe and elsewhere, complementary and integrative medicine is being integrated into supportive patient care.
In Israel similar trend is observed and 8 integrative oncology services has been established around the country in the majority of oncology centers. Homeopathy is one of the CIM modalities utilized by patients with cancer. It is widely practiced worldwide, especially in Europe, Asia, and Latin America.
In the United States, during the 1990s, sales of homeopathic medicines grew at an annual rate of 20-25%, and in the 2015 US National health statistics report, homeopathy was mentioned as used by over 5 million people.
This modality involves detailed interview that emphasizes the unique characteristics of symptoms experienced by patients followed by utilizing highly diluted substances. Dilutions that are above 12c (dilution of 10-24 actually do not have the original substance), which are commonly used in homeopathy, reflect that the original material is not in this remedy. As a result of this understanding this complementary therapy remains one of the debated modalities in CIM.
Some mention that patients seek that method of care due to the fact that this approach emphasizes empathic listening to patients' concerns and worries, and the effect of the actual remedy, due to its high dilution, reflect a placebo response.
On the other hand, some clinical studies reveal that the use of homeopathy in cancer care, as a supportive approach, reflects clinical benefit that is not attributed to placebo, without risk of side effects or interactions with the conventional oncology approach.
In one prospective observational study done in Germany with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (n = 259), and one cohort with conventionally treated cancer patients (n = 380). It was observed that an improvement in quality of life was observed in patients taking the addition of homeopathic treatment, as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.
Another recent descriptive study that was conducted in France in three oncology centers in one city. Researchers observed that homeopathy was used in 30% of the cancer patients. (n=633) The homeopathy was used as an additional supportive measure. Fatigue was one of the leading symptoms that improved in 80% of the patients that homeopathy was added to their care.
An Israeli study evaluated the adherence to homeopathic treatment among cancer patients who received a CIM consultation (n=124). The authors found that homeopathy treatment was feasible, with two-thirds of patients acquiring and self-administering the remedies as prescribed. Fatigue was one of the main symptoms that patients felt that improved with the addition of homeopathy.
In another prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter, phase III study at the University of Vienna, researchers evaluated the possible effects of additive homeopathic treatment compared with placebo in 150 patients with stage IV Non-Small Cell Lung Cancer (NSCLC). Researchers found that there was a significant improvement of quality of life measures in the additive homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment. In addition, median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as, versus control (228 days; p < .001).
Homeopathy is considered safe and without adverse effects, neither direct (i.e., toxic effects) nor indirect (i.e., interactions with conventional anticancer agents).
In this study, patients affected by cancer that attend the oncology department in Rambam Health Campus, and wish to utilize the CIM service, will be offered this option of care.
The aim of the present study is therefore to evaluate the feasibility of the process of integrating homeopathy as a potential treatment option for symptom control and improvement in quality of life in cancer patients, in a comprehensive cancer center.
This observational study will evaluate three main ingredients:
- Obtaining main concerns of patients that agree to utilize this method
- Patient acceptance of this supportive approach that will be reflected in obtaining and self-administering the remedies as prescribed.
- Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters, at the initial evaluation, and during follow up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility of a supportive approach | – | Behavioral: Feasibility of a supportive approachEvaluating a feasibility of an approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that elect to use complementary and integrative medicine during cancer care and make a choice to use homeopathy as part of this use
Key inclusion criteria (5 listed)
- • 18 years of age or older
Key exclusion criteria (3 listed)
- • Inability to understand the intent of the study and follow the instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility of a supportive approachEvaluating reasons for patients to use the approach | Behavioural | Feasibility of a supportive approach |
Primary outcome
Feasibility of a supportive approach
Time frame: 6-12 weeks
Questionnaire
Quality of life- Level of Distress
Time frame: 6-12 weeks
Distress thermometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 38842016Theunissen I, Bagot JL. Supportive cancer care: is integrative oncology the future? Curr Opin Oncol. 2024 Jul 1;36(4):248-252. doi: 10.1097/CCO.0000000000001027. Epub 2024 Feb 23.
- Background: PubMed 26210222Frenkel M. Is There a Role for Homeopathy in Cancer Care? Questions and Challenges. Curr Oncol Rep. 2015 Sep;17(9):43. doi: 10.1007/s11912-015-0467-8.
- Background: PubMed 33010094Frass M, Lechleitner P, Grundling C, Pirker C, Grasmuk-Siegl E, Domayer J, Hochmair M, Gaertner K, Duscheck C, Muchitsch I, Marosi C, Schumacher M, Zochbauer-Muller S, Manchanda RK, Schrott A, Burghuber O. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study. Oncologist. 2020 Dec;25(12):e1930-e1955. doi: 10.1002/onco.13548. Epub 2020 Nov 7.
- Background: PubMed 34027702Dolev T, Ben-David M, Shahadi I, Freed Y, Zubedat S, Aga-Mizrachi S, Brand Z, Galper S, Jacobson G, Avital A. Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019470. doi: 10.1177/15347354211019470.
- Background: PubMed 29094627Samuels N, Freed Y, Weitzen R, Ben-David M, Maimon Y, Eliyahu U, Berger R. Feasibility of Homeopathic Treatment for Symptom Reduction in an Integrative Oncology Service. Integr Cancer Ther. 2018 Jun;17(2):486-492. doi: 10.1177/1534735417736133. Epub 2017 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Suleymanov, RN study director
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Quality of Life, run by Rambam Health Care Campus 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 5 inclusion and 3 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 7 Aug 2025. 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 Moshe Frenkel, MD (972523311255, frenkelm@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a supportive approach (time frame: 6-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833165, which also lists 5 linked publications.
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 7 Aug 2025.