NCT05833165

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Jan 2028

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

August 7, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

April 3, 2023

Last Update Submit

August 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility of a supportive approach

    Questionnaire

    6-12 weeks

  • Quality of life- Level of Distress

    Distress thermometer

    6-12 weeks

Study Arms (1)

Feasibility of a supportive approach

Evaluating a feasibility of an approach

Behavioral: Feasibility of a supportive approach

Interventions

Evaluating reasons for patients to use the approach

Feasibility of a supportive approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 30900, Israel

RECRUITING

Related Publications (5)

  • 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.

    PMID: 38842016BACKGROUND
  • Frenkel 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.

    PMID: 26210222BACKGROUND
  • Frass 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.

    PMID: 33010094BACKGROUND
  • Dolev 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.

    PMID: 34027702BACKGROUND
  • Samuels 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.

    PMID: 29094627BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Maria Suleymanov, RN

    Rambam Health Care Campus

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 27, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

August 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations