Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Nervous System Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Peripheral Nervous System Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Neuromuscular Diseases

Lymphosarcoma

No other active treatment or sham acupuncture for this symptoms

Acupuncture treatment will be performed by licensed doctors in Traditional Korean Medicine using 0.20 mm (diameter) X 0.40 mm (length) sized disposable acupuncture 3 times per week for 3 weeks. Acupuncture points are GV20, GB20 (bilateral), LI11 (bilateral), LI10 (bilateral), EX-UE9 (bilateral), ST36 (bilateral), ST40 (bilateral), and EX-LE10 (bilateral). Each session lasts 20-30 minutes.

Acupuncture

Chang Woo Han, PhD

Ho-Jin Shin, MD, PhD

Eui-Hyoung Hwang, PhD

Ho-Jin Shin, PhD

The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.

Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study

Pusan National University Hospital

Neoplasms, Second Primary

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Trastuzumab

Bleomycin

Cisplatin

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Patients with toxicity during/after treatment with anthracylines.

Patients without toxicity during/after treatment with anthracylines.

Patients with toxicity during/after treatment with trastuzumab.

Patients without toxicity during/after treatment with trastuzumab.

Patients with toxicity during/after treatment with cisplatin.

Patients without toxicity during/after treatment with cisplatin.

Patients with toxicity during/after treatment with bleomycin.

Patients without toxicity during/after treatment with bleomycin.

Chemotherapy regimen containing anthracyclines.

Anthracyclines

Systemic treatment including trastuzumab.

J.A. Gietema, MD, PhD

L.C. Steggink, MD

Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment is largely unknown. Unraveling extreme cardiovascular toxic responses in cancer patients may help understand the pathophysiology of cardiovascular toxicity of these agents and help in understanding the more subtle, long-term cardiovascular side effects that affect a larger part of cancer survivors. With induced pluripotent stem cells we will obtain patient-derived cells to recapitulate and mimic and study pathological (cardiovascular) responses and (cardiovascular) toxicity in vitro.

Urine sample, blood sample, germline DNA, skin fibroblasts.

Investigating Cardiovascular Adverse Events Related to Cancer Treatment

Investigating Cardiovascular Adverse Events Related to Cancer Treatment: a Study of Extreme Toxicity Using Induced Pluripotent Stem Cells

Comparison between iPSC-derived cells from toxicity cases and controls, for each of the four different agents.

Correlate the findings from the iPSC-derived cells with the clinical phenotype of (cardiovascular) toxicity, assessed by circulating biomarkers and cardiac or vascular imaging.

University Medical Center Groningen

Patients with cancer referred for systemic treatment of the outpatient clinic at the departments of Medical Oncology at participating centres.

Laurien Buffart, PhD

Calvin Brouwer, Msc

Joeri Douma, MD

Joeri Douma, PhD

Evelien Kuip, MD

Laurien Buffart

Leni van Doorn

Verheul Henk, Prof

The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. The investigators want to test whether the number of steps per day, both before and during treatment, are related to possible side effects or other physical complaints of the treatment using a smartphone. Knowledge about this relationship gives us possible starting points to prevent and/or reduce side effects and improve treatment outcomes. Additional research would then be needed.

The investigators also want to investigate whether these daily measurements are feasible for patients undergoing treatment.

Participation in the study involves measuring daily physical activity from the week before treatment until the first 3 months of treatment have been completed. This is done by tracking daily steps with patients own phone using the OncoSTAPP application.

Rationale: Systemic treatment of patients with cancer has a multimodal approach with the goal of balancing quantity and quality of life. Treatment decisions are influenced by tumour and patient-related characteristics. Additionally, in clinical practice performance status is used to identify whether a patient is sufficiently fit for systemic treatment, as it has shown to be a valid prognostic factor for survival and adverse events during treatment. However, treatment-related toxicities and hospitalisations occur frequently during systemic treatment.

The disadvantages of performance status assessed with ECOG or Karnofsky, is that it is a subjective measurement which is prone to bias and has high interobserver variability. Also a patient's self-reported physical function is significantly associated with shorter (progression-free) survival, but it is also subjective and is prone to multiple forms of bias. Objective assessment of physical function might be a good alternative to counteract these shortcomings. A higher level of physical activity is associated with a reduction in cancer specific mortality and can be measured with accelerometers, pedometers or multisenor systems like smartphones.

Wearable measured step count assessed with a wrist worn device provided by the investigators has shown to be associated with adverse events. However, these devices cannot be provided to all patients in clinical practice.

Recently, the investigators showed that the smartphones' assessments of physical activity (step count), have excellent agreement with accelerometer assessments of physical activity and good test-retest reliability. Furthermore this smartphone measurements were associated with early trial discontinuation in phase 1/2 cancer trials.

The investigators hypothesize that a low baseline and/or a reduction in physical activity (step count) measured with smartphones will be predictive for clinically relevant adverse events during systemic treatment. Adding objective information of physical function in the process of selecting the best treatment for a patient may help prevent unnecessary adverse events. Additionally, a detection of a decline in physical activity during treatment may identify upcoming adverse events early, allowing timely management/support. This may help to optimize treatment and quality of life.

Objective: Primary objectives: 1) To determine whether baseline physical activity, measured by the number of steps per day with a smartphone, is associated with clinically relevant adverse events during treatment.

2) To determine whether changes in physical activity, measured by the number of steps per day with a smartphone, are associated with clinically relevant adverse events during treatment.

Clinically relevant adverse events during treatment are defined as hospitalizations, early treatment discontinuation, relative dose intensity below 70% and mortality.

Secondary: Patients' acceptability of the application. The association of physical activity with relative dose intensity, progression free and overall survival. The association between the oncologists' estimates and clinically relevant adverse events during treatment, and the possible added value of objective assessments of physical activity.

Study design: Prospective observational cohort study.

Study population: 411 patients with cancer referred for systemic treatment at the departments of Medical Oncology at participating centres.

Intervention: N/A.

Main study parameters/endpoints: Collection of daily number of steps will start in the week before treatment and will continue for the first 3 months of systemic treatment. Mean number of steps per day will be measured passively with a smartphone application on patients' own smartphones. Primary endpoint is any clinically relevant adverse events during treatment, defined as hospitalizations, significant dose modifications of treatment and mortality.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this study will not cause any additional risks or expected benefits for participants. No extra visits to the hospital will be necessary. It will provide us knowledge, which may be used in the future to better select patients for systemic treatment.

Patients will be asked to carry their smartphone on them during the duration of the study.

Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count

Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count - Prospective Cohort Study

No current plans for data sharing. Patients gave informed consent to share data with studies in line with the current research question. Data availible on request.

Comorbidities of the patiënt, with the Charlson Comorbidity Index (CCI)

tumour type and stage, pathology findings.

previous treatments related to current tumour. including surgery, radiotherapy and all systemic treatments

treatment characteristics, type of systemic treatment

Total number of medications before current systemic treatment.

laboratory finding captured as routine care at enrolement, Hemoglobin (mmol/L)

laboratory finding captured as routine care at enrolement, Leukocytes (10\*\*09/L)

laboratory finding captured as routine care at enrolement, Trombocytes (10\*\*09/L)

laboratory finding captured as routine care at enrolement, Neutrophils (10\*\*09/L)

laboratory finding captured as routine care at enrolement, Lymphocytes (10\*\*09/L)

laboratory finding captured as routine care at enrolement, Sodium (mmol/L)

laboratory finding captured as routine care at enrolement, Urea (mmol/L)

laboratory finding captured as routine care at enrolement, Creatinine (umol/L)

laboratory finding captured as routine care at enrolement, Creatinine clearance (ml/min/1.73m2) CKD-EPI-GFR

laboratory finding captured as routine care at enrolement, alanine aminotransferase (U/L) (ALAT)

laboratory finding captured as routine care at enrolement, Aspartate aminotransferase (U/L) (ASAT)

laboratory finding captured as routine care at enrolement, Serum Lactate Dehydrogenase (U/L) (LDH)

laboratory finding captured as routine care at enrolement, Alkaline phosphatase (U/L)

laboratory finding captured as routine care at enrolement, Serum Albumin (g/L)

laboratory finding captured as routine care at enrolement, C-reactive protein (mg/L)

Mean number of steps per day measured with a smartphone. At baseline and during treatment

Hospitalizations during treatment related to the therapy; will be combined into Clinically relevant adverse events during treatment

Early treatment discontinuation, within the first 3 months; will be combined into Clinically relevant adverse events during treatment

Relative dose intensity (RDI) below 70%; will be combined into Clinically relevant adverse events during treatment

Mortality due to treatment toxicity; will be combined into Clinically relevant adverse events during treatment

The percentage of planted dose and time between doses will be retrieved form patients' medical records (EPIC). The RDI will be calculated by total percentage of given dose divided by the proportion of the actual time in relation to the standard time. RDI=(Total percentage of given dose)/((Actual time)/(Standard time))\*100

The Eastern Cooperative Oncology Group/World Health Organization Performance Status (ECOG/WHO-PS) will be determined by the treating physician before treatment as stated in the current treatment guidelines of the departments of Medical Oncology. scale 0 to 5, with 0 denoting perfect health and 5 death.

Question if patients are defined as at high (\>50%) or low risk of dose limiting (\>25% or discontinuation) toxicity during the first 3 months of systemic treatment. This will be documented in patients' medical records (e.g. EPIC).

Overall survival is defined as the time between start of trial participation and death of any cause and will be tracked via the patients' medical records (e.g. EPIC).

Progression free survival is defined as the time between start of systemic treatment and the clinically or radiologically confirmation of progressive disease (established via RECIST-criteria) and will be tracked via the patients' medical records (e.g. EPIC).

Validity of the smartphone application will be assesed by the proportion of patients correctly collected the data.

A consecutive sample of patients will be contacted for a short interview about the use of the smartphone application, until data saturation. Any spontaneously reported reactions about the smartphone application will be collected.

Erasmus Medical Center

Medisch Centrum Leeuwarden

Radboud University Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Hyperthermia

Fever

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Standard chemotherapy protocol combined with whole body hyperthermia

standard chemotherapy protocol for advanced NSCLC

standard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC

chemotherapy & WBH

LIU WENCHAO, professor

GUO JUNZHAO, DOCTOR

LIU WENCHAO, PROFESSOR

Millions of patients die of non-small cell lung cancer (NSCLC) every year. There are several methods to treat NSCLC, including surgery, chemotherapy, radiotherapy and bioimmuotherapy. Recently, hyperthermia therapy has played an important role in neoplasm therapy. It has showed some effect in NSCLC both in animal experiment and clinical practice, yet there is little literature about Whole-body Hyperthermia (WBH) with neoplasm. The investigators decides to develop this randomized contrasted multicenter clinical study to testify to the effect of chemotherapy combined with WBH to treat stage IIIB/IV Non Small Cell Lung Cancer (NSCLC).

Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer

A Randomized Contrasted Polycentric Clinical Study About Chemotherapy Combined With Whole-body Hyperthermia(WBH)to Treat Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Xijing Hospital

Digestive System Diseases

Adenocarcinoma

Stomach Neoplasms

Neoplasms, Glandular and Epithelial

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Micronutrients

Hematinics

Vitamins

Docetaxel

Oxaliplatin

Leucovorin

Levoleucovorin

Tubulin Modulators

Antimitotic Agents

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

LOTS as one cycle:

Leucovorin (30 mg) twice daily per oral, day 1 to 7; Oxaliplatin (85 mg per square meter) intravenously, day 1; Docetaxel (40 mg per square meter) intravenously, day 1; S-1 (35 mg per square meter) twice daily per oral, day 1 to 7

Pre-operative part:

Four cycles of LOTS every two weeks

Operative part:

Curative gastrectomy or gastroesophagectomy plus D2 lymphadenectomy

Post-operative part:

Four cycles of LOTS every two weeks

leucovorin, oxaliplatin, docetaxel, S-1

Clinical Trial Center, National Cheng-Kung University Hospital

Chih Chieh Yen, M.D.

I Shu Chen, M.D.

Li Yuan Bai, M.D., Ph.D.

Ying Jui Chao, M.D.

Ting Kai Liao, M.D.

Ping Jui Su, M.D.

I Ting Liu, M.D.

Kwang Yu Chang, M.D., Ph.D.

Chien Jui Huang, M.D.

Ming Huang Chen, M.D., Ph.D.

Chia Jui Yen, M.D., Ph.D.

Yan Shen Shan, M.D., Ph.D.

The aim of the trial is to investigate the clinical efficacy and toxicity of perioperative chemotherapy with leucovorin, oxaliplatin, docetaxel and S-1 (LOTS) in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who receive a curative surgery.

The study is an open-label, single-arm, single-country and multi-center phase II investigator-initiated trial. Patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who enroll the trial will receive perioperative chemotherapy with LOTS (14 days as a cycle) 4 cycles every 2 weeks, followed by operation and another 4 cycles every 2 weeks post-operatively. The primary outcome is pathological response or curative resection rate. The secondary outcome includes recurrence-free survival, overall survival, disease control rate, protocol completion rate and adverse events.

Single intervention arm with trial treatment

Perioperative Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Locally Advanced Gastric or Gastroesophageal Junction Cancer

A Phase II Trial of Perioperative Chemotherapy With Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

All individual participant data which are processed with de-identification procedures and underlie results in a scientific publication

the tumor pathological response after pre-operative chemotherapy with LOTS plus curative surgery. The pathological response is defined by tumor evaluation of complete, partial or no response according to tumor regression grading (TRG)

the rate of margin-free (R0) resection in the absence of macro- or microscopic residual tumors remaining at the primary tumor bed

the time interval from the initiation of trial treatment to disease recurrence, progression or death at any causes

the time interval from the initiation of trial treatment to death at any causes

the rate of patients remaining in disease control (complete, partial response and stable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines version 1.1) lasting at least three months

the rate of patients completing the pre-specified protocol treatment

the rate of protocol treatment-emergent adverse events, as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupuncture for Chemotherapy-induced Peripheral Neuropathy	NCT01892852	Peripheral Neur... Toxicity Due to... Lymphoma Multiple Myelom...	Acupuncture	18 Years -	Pusan National University Hospital
Investigating Cardiovascular Adverse Events Related to Cancer Treatment	NCT03199300	Toxicity Due to... Cardiovascular ... Cancer, Treatme...	Anthracyclines Trastuzumab Cisplatin Bleomycin	18 Years -	University Medical Center Groningen
Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count	NCT05927636	Cancer Systemic Treatm... Physical Activi... Toxicity Due to...		18 Years -	Radboud University Medical Center
Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer	NCT01493011	Non-small Cell ... Toxicity Due to...	chemotherapy & ...	18 Years - 75 Years	Xijing Hospital
Chemotherapy Combined With Whole-body Hyperthermia to Treat Stage IIIB/IV Non Small Cell Lung Cancer	NCT01493011	Non-small Cell ... Toxicity Due to...	chemotherapy & ...	18 Years - 75 Years	Xijing Hospital
Perioperative Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Locally Advanced Gastric or Gastroesophageal Junction Cancer	NCT04999332	Gastric Cancer Gastric Adenoca... Effects of Chem... Toxicity Due to...	leucovorin, oxa...	20 Years -	National Cheng-Kung University Hospital
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life	NCT02848807	Toxicity Due to... Cancer Cachexia Metastatic Colo... Quality of Life Dietary Modific...	NUTRIDRINK Comp...	18 Years -	University Clinical Centre, Gdansk
Pilot Study of an NTproBNP Guided Strategy of Cardioprotection	NCT04737265	Cardiotoxicity Toxicity Due to... Breast Cancer Lymphoma Cardiomyopathie... Heart Failure	Biomarker Guide...	18 Years -	Abramson Cancer Center at Penn Medicine
Impact of Gonadotoxic Therapies on Fertility	NCT05885048	Cancer Fertility Issue... Fertility Prese... Toxicity Due to... Toxicity Due to... Effects of Immu...	Blood samples f... Sperm samples f... Satisfaction ev... Quality of Life...	14 Years - 50 Years	Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Systemic Treatment Related Toxicity Identified With a Smartphone APPlication Measuring Step Count	NCT05927636	Cancer Systemic Treatm... Physical Activi... Toxicity Due to...		18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for toxicity due to chemotherapy