Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05833165
Status:
RECRUITING
Last Update Posted:
2023-04-27
First Post:
2023-04-03
Brief Title:
Feasibility of Integrating Homeopathic Approach in a Comprehensive Cancer Center
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Feasibility of Integrating Homeopathic Approach in a Comprehensive Cancer Center
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 n633 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 n124 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 ie toxic effects nor indirect ie 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
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 n633 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 n124 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 ie toxic effects nor indirect ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None