Chemotherapy

About Chemotherapy Clinical Trials (Click to Open)

Chemotherapy Clinical Trials

General Purpose:

Chemotherapy Clinical TrialsIf you have been diagnosed with cancer, chances are you have heard the word chemotherapy since receiving your diagnosis. You may also be unnerved by the word, which you may equate in your mind with weight loss, fatigue, and an overall sense of malaise. Historically, many chemotherapy drugs have caused such side effects, however newer and less-toxic drugs have been discovered in recent years.

Many are also easier to administer, with dosing often accomplished by simply taking a few pills, rather than being hooked up to an IV for an extended period of time. New chemotherapy drugs are constantly being investigated in clinical trials, which can be welcome information for a cancer patient whose tumor has failed to respond to standard chemotherapy.  

What Will Chemotherapy Clinical Trials Be Like?

Clinical trials in chemotherapy are done when researchers think that a new chemotherapy drug (or a new combination of drugs) may help to cure or control the growth of a particular cancer. After the new chemotherapy drug has been tested in the Chemotherapy Clinical Trialslaboratory as well as in animals, they are then tested in human clinical trials in order to determine their safety and effectiveness.

Clinical trials in chemotherapy are conducted in phases, and the phase of the study will ultimately determine the specific procedures that you will undergo. Below is a brief summary of what can be expected:

  • Blood tests
  • Urine tests
  • Physical exams and/or phone interaction with research personnel.
  • Blood and/or urine tests may be performed to monitor how your body metabolizes the medication.
  • Imaging procedures such as computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.        
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
  • Pain assessments
  • Performance status measures 

Typical Chemotherapy Clinical Trial Protocol:

The design of a specific chemotherapy protocol depends on the drug(s) being Chemotherapy Clinical Trialsinvestigated, the cancer being treated, and a number of other study-specific factors. On a broad level, the specific phase of the study will dictate the nature of the clinical trial and how it is conducted. A brief summary of typical clinical trial designs for chemotherapy related studies is below:

Phase I:  These studies are small and typically enroll no more than a few dozen individuals. They are used to test an experimental chemotherapy drug for the first time in order to evaluate its safety, determine the highest dose that can be administered with the fewest side effects, and identify what side effects are most common.

Phase II:  These studies involve greater numbers of patients than phase I studies to further investigate the chemotherapy drug’s effectiveness and safety. Its impact on the development/progression of the cancer may also be examined. 

Phase III:  These studies continue to investigate the chemotherapy drug in large numbers of patients (over 1,000+) to confirm that it is effective and safe, continue to monitor and confirm possible side effects, compare it to standard chemotherapy drugs, and collect additional information (such as quality of life information, cancer-specific information, etc.)

Phase IV:  These studies, often called “post-marketing studies” are conducted once a drug has been approved for sale and are commercially available. They are used to provide additional information regarding the risks and benefits of the chemotherapy drug, as well as the conditions for its optimal use.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug Chemotherapy Clinical Trialscompared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Methods:

Although there are exceptions, most chemotherapy clinical trials (especially those in early phases of research) investigate the drug in patients with a specific type of cancer. Therefore, the best approach for identifying relevant chemotherapy-oriented clinical trials is to search in relation to the type of cancer you have.

For example, if you have been diagnosed with lung cancer, the following search terms might be the most useful: “lung cancer chemotherapy,” “lung cancer treatment,” and “chemotherapy lung.” If you have breast cancer, substituting the word “breast” for the word “lung” will likely provide the most relevant results, and so on. 

Current Search Term:

“Chemotherapy”

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Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy


Condition:   Chemotherapy-induced Neutropenia
Interventions:   Drug: Plinabulin;   Drug: Pegfilgrastim;   Other: Saline Placebo;   Other: D5W Placebo
Sponsors:   BeyondSpring Pharmaceuticals Inc.;   Chiltern International Inc.;   ICON plc
Recruiting - verified November 2016


The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs


Condition:   Chemotherapy-induced Peripheral Neuropathy
Intervention:   Device: electroacupuncture
Sponsor:   Tianjin Medical University Cancer Institute and Hospital
Not yet recruiting - verified February 2017


A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor


Condition:   Chemotherapy-induced Thrombocytopenia
Intervention:  
Sponsor:   Angde Biotech Pharmaceutical Co., Ltd.
Not yet recruiting - verified August 2016


Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy


Condition:   Chemotherapy-induced Peripheral Neuropathy
Intervention:   Behavioral: Whole-body vibration training
Sponsors:   University of Basel;   German Sport University, Cologne;   University Hospital of Cologne;   University of Freiburg;   University Hospital, Basel, Switzerland
Recruiting - verified March 2017


Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy


Condition:   Antineoplastic Combined Chemotherapy Protocols
Interventions:   Drug: Pegylated Liposomal Doxorubicin;   Drug: Cyclophosphamide;   Drug: Taxotere;   Drug: Dexrazoxane (DZR);   Drug: vitamin B;   Drug: Doxorubicin;   Procedure: Breast Conserved Surgery;   Procedure: Modified Radical Mastectomy;   Procedure: Sentinel Lymph Node Biopsy(SLNB)
Sponsor:   Jilin University
Recruiting - verified November 2016


Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting


Condition:   Chemotherapy-induced Nausea and Vomiting
Interventions:   Drug: Aprepitant+palonosetron+dexamethasone;   Drug: palonosetron+dexamethasone
Sponsor:   Wuhan Union Hospital, China
Not yet recruiting - verified October 2016


Optimized Multi-modality Machine Learning Approach During Cardio-toxic Chemotherapy to Predict Arising Heart Failure


Condition:   Toxicity Due to Chemotherapy
Intervention:  
Sponsors:   RWTH Aachen University;   Technion, Israel Institute of Technology
Not yet recruiting - verified October 2016


Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy


Condition:   Intraperitoneal Chemotherapy
Intervention:   Device: Thermowire
Sponsor:   Centre Hospitalier Universitaire Dijon
Completed - verified April 2017


Erythropoietin and Iron Supplementation for Patients With Chemotherapy-induced Anaemia


Condition:   Chemotherapy-induced Anaemia
Interventions:   Drug: Erythropoietins (EPO);   Drug: Aggressive iron dextran supplementation;   Drug: Erythropoietins (EPO);   Drug: Sustained iron dextran supplementation
Sponsor:   Shanghai East Hospital
Not yet recruiting - verified October 2016


Aromatherapy for Chemotherapy-induced Symptoms


Condition:   Chemotherapy Symptoms
Interventions:   Drug: Ginger;   Drug: Lavender;   Drug: Orange;   Drug: Jojoba
Sponsor:   University of Rochester
Recruiting - verified September 2016


The Effectiveness and Cost-effectiveness of Acupuncture in Managing Chemotherapy-induced Peripheral Neuropathy


Condition:   Chemotherapy-induced Peripheral Neuropathy
Interventions:   Procedure: Acupuncture;   Procedure: Standard care
Sponsors:   The Hong Kong Polytechnic University;   Prince of Wales Hospital, Shatin, Hong Kong;   Chinese University of Hong Kong
Recruiting - verified November 2016


Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondandsetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)


Condition:   Chemotherapy-induced Nausea and Vomiting
Interventions:   Drug: Fosaprepitant;   Drug: Placebo for fosaprepitant;   Drug: Ondansetron;   Drug: Dexamethasone;   Drug: 5-HT3 antagonist
Sponsor:   Merck Sharp & Dohme Corp.
Terminated - verified March 2017


Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting


Condition:   Chemotherapy-induced Nausea and Vomiting
Interventions:   Drug: Olanzapine;   Drug: Aprepitant;   Drug: Palonosetron;   Drug: Dexamethasone
Sponsors:   First Affiliated Hospital of Harbin Medical University;   Harbin Medical University
Completed - verified June 2016


Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study


Condition:   Chemotherapy-Induced Neutropenia
Intervention:   Biological: Nivestim®
Sponsors:   Pfizer;   Hospira, now a wholly owned subsidiary of Pfizer
Recruiting - verified February 2017


Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management


Condition:   Chemotherapy-induced Peripheral Neuropathy
Intervention:   Drug: Dextromethorphan
Sponsors:   University Hospital, Clermont-Ferrand;   Dr Gisèle PICKERING;   Dr Dominique JOLY / Dr Christine VILLATTE;   Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD;   Pr Claude DUBRAY
Recruiting - verified July 2016



Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study


Condition:   Chemotherapy-induced Nausea and Vomiting
Intervention:   Drug: Olanzapine
Sponsors:   The Hospital for Sick Children;   Pediatric Oncology Group of Ontario
Completed - verified September 2016


Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy


Condition:   Chemotherapy Induced Nausea and Vomiting
Interventions:   Drug: Olanzapine;   Drug: Aprepitant
Sponsor:   Indiana University
Completed - verified February 2017


Study of Romiplostim for Chemotherapy Induced Thrombocytopenia


Condition:   Isolated Chemotherapy-induced Thrombocytopenia
Intervention:   Biological: romiplostim
Sponsors:   Memorial Sloan Kettering Cancer Center;   Amgen
Recruiting - verified March 2017


Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy


Condition:   Chemotherapy-induced Peripheral Neuropathy
Interventions:   Device: photobiomodulation;   Other: Sham treatment;   Other: Physiotherapy
Sponsor:   University of Minnesota - Clinical and Translational Science Institute
Active, not recruiting - verified September 2016


Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation


Condition:   Dexamethasone-induced Hiccup in Chemotherapy
Intervention:   Drug: methylprednisolone
Sponsors:   Chung-Ang University;   Gyeongsang National University Hospital;   Dong-A University Hospital;   Samsung Medical Center
Completed - verified April 2017


Nutrition Intervention During Chemotherapy


Condition:   Cancer Patients Receiving Chemotherapy or Chemoradiotherapy
Intervention:   Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks)
Sponsor:   Texas A&M University
Recruiting - verified October 2016


Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.


Condition:   Chemotherapy-induced Febrile Neutropenia
Intervention:  
Sponsor:   Amgen
Completed - verified February 2017


Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy


Condition:   Chemotherapy-Induced Peripheral Neuropathy
Interventions:   Drug: Olesoxime (TRO19622);   Drug: Placebo Control
Sponsor:   Hoffmann-La Roche
Completed - verified November 2016


A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)


Condition:   Chemotherapy-Induced Nausea and Vomiting
Interventions:   Drug: Experimental: aprepitant;   Drug: Experimental: fosaprepitant;   Drug: Comparator: ondansetron;   Drug: Ondansetron;   Drug: Dexamethasone
Sponsor:   Merck Sharp & Dohme Corp.
Terminated - verified March 2017

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