Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Quality of Life

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules

Additive classical homeopathy

Homeopathic placebo globules every 2 to 3 months

Homeopathic Placebo globules

Michael Frass, Prof. Dr.

The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment.

The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.

The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.

Additive Homeopathy in Cancer Patients

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Study Evaluating Quality of Life in Patients With Advanced Malignant Lung Tumors With or Without "add-on" Homeopathy

Quality of life was evaluated by using the Global Health Status assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), which was completed by participants throughout the study.

The score of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status.

Survival was assessed by chart review, at every study visit (every 9 weeks throughout the trial), and by information of the central mortality registry of Austria

Medical University of Vienna

Principal Investigator, Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients

The adverse events reporting in this study differed from the definition of clinicaltrials.gov.

Treatment-related (serious) and non-treatment-related adverse events have been reported.

No severe treatment-related (serious) or non-treatment-related adverse event has been identified attributed to the study medication.

Cancer patients received homeopathic placebo remedies.

Treatment emergent and serious adverse events were documented.

Homeopathic Placebo Globules

Lung cancer patients receive additive classical homeopathy with homeopathic remedies

Treatment emergent and serious adverse events were documented.

Additive Classical Homeopathy in Cancer Patients

Patients received no intervention.

Treatment emergent and serious adverse events were documented.

No Intervention Group

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules

Additive classical homeopathy: Homeopathic remedies every 2 to 3 months

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules

Homeopathic Placebo globules: Homeopathic placebo globules every 2 to 3 months

Additive Homeopathic Placebo Globules

Lung cancer patients receiving conventional chemo- and/or radiation therapy but neither homeopathic remedies nor homeopathic placebo globules, these patients served as a non-intervention control group

No Intervention

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Austria

Region of Enrollment

At baseline the quality of life questionnaire (EORTC-QLQ-C30) was completed by all participating subjects receiving placebo or homeopathy

The quality of life assessment was done in the two intervention groups (homeopathy or placebo), but was not done in control patients who received no intervention.

Therefore, no data are presented for the "No Intervention" group.

EORTC-QLQ-C30

Michael Frass, MD

Cancer patients received homeopathic placebo remedies

Lung cancer patients receive additive classical homeopathy with homeopathic remedies

Lung cancer patients received conventional anti-cancer therapy, but neither homeopathic remedies nor homeopathic placebo globules. Data not collected for the no Intervention Group.

Data not collected for the no Intervention Group

EORTC-QLQ-C30 Score

Only those groups were compared who received an intervention

Survival

The patients in this group received no intervention

Overall Study

JS201 is administered intravenously Q3W at the corresponding dose.

JS201

Pan He, Postgraduate

Ziping Wang, Prof

Ning Xu, Prof

Zhiming Li, Prof

Jundong Li, Prof

Xicheng Wang, Prof

Fangjian Zhou, Prof

Aimin Zang, Prof

Yanqiao Zhang, Prof

Yanqiu Zhao, Prof

Shujun Yang, Prof

Qingxia Fan, Prof

Guiling li, Prof

Hongjian Guo, Prof

Yong Mao, Prof

Yong Liu, Prof

Bin Hu, Prof

Bo Liu, Prof

Peng Zhang, Prof

Jiyan Liu, Prof

Yun Fan, Prof

Li Zhang, Prof

This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.

Clinical Study of JS201 in Patients With Advanced Malignant Tumors

An Open-label, First-in-human, Dose Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of JS201 in Patients With Advanced Malignant Tumors

DLT is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 21 days after the first dose (NCI-CTCAE v5.0);

An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.

A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect

IrAE is assessed according to the judgement of investigators

The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria (solid tumors) or Lugano criteria (2014, lymphoma), including complete response (CR) and partial response (PR).

DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.

The efficacy evaluated by the investigator per RECIST 1.1 criteria (solid tumors) or Lugano criteria (2014, lymphoma), including CR, PR and stable disease (SD);

PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.

OS is defined as the time from the date of randomization to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Additive Homeopathy in Cancer Patients	NCT01509612	Malignant Tumor...	Additive classi... Homeopathic Pla...	18 Years -	Medical University of Vienna
Clinical Study of JS201 in Patients With Advanced Malignant Tumors	NCT04956926	Patients With A...	JS201	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for patients with advanced malignant tumors