Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Stomatitis

Mucositis

Oropharyngeal Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Hypopharyngeal Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Herbal and Botanical

Kava

Mouthwash with Homeodent® is started on the first day of irradiation, then continued until the end of the irradiation period or until occurrence of grade ≥3 mucositis. In case of grade ≥3 mucositis, patients are instructed to mouthwash with Sodium Bicarbonate solution until complete disappearance of mucositis or until the end of irradiation.

Mouthwash with sodium bicarbonate is started on the first day of irradiation, then continued until the end of the irradiation period. In case of grade ≥3 mucositis, mouthwash is continued until complete disappearance of the mucositis or until the end of irradiation.

In both arms, after the end of irradiation, patients can receive treatment with Sodium Bicarbonate solution until complete disappearance of the mucositis.

Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.

Homeodent®

Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing

1.4% Sodium Bicarbonate solution

Pascal POMMIER

The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.

This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. However, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. The treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. This study will evaluate the efficiency of mouthwash with Homeodent® in a large randomized trial.

Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer

Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer

BOIRON

Centre Leon Berard

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

two complex naturopathic add-on therapies, leaflet 5-a-day

Cornelia U. von Hagens, MD

The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.

patients were randomized to receive: (a) individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000 F.I.P. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for the control group.

Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before and 3-5 weeks after the third cycle of chemotherapy. Secondary endpoints were the other subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D.

Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer

Prospective Randomized Trial With Complementary Therapies During Chemotherapy at the Women's Hospital of the University of Heidelberg

Hector-Stiftung

Cefak KG, Kempten

Ursapharm, Saarbrücken

Schwabe-Wenex International Ltd

Heidelberg University

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Patients with Chronic Myeloid Leukemia taking TKI with a molecular response \< 4,5 Log will participate to pharmaceutical conciliation.

Patients with pharmacokinetic and/or pharmacodynamics interactions will be proposed to participate to educational sessions to discuss about treatments taken and modifications possibilities.

Pharmaceutical intervention

Sandrine Menguy, MD, PhD

Mathilde Maison, MsC

Denis GUYOTAT

Karine AUGEUL MEUNIER

Silvia Maria BEZSERA

Emilie CHALAYER

Philippe COLLET

Jérôme CORNILLON

Ludovic FOUILLET

Fressia HONEYMAN

Caroline LEJEUNE

Thierry MURON

Gilbert SOGLU

Emmanuelle TAVERNIER TARDY

Pauline DOUCEY

Fabien FORGES

Sophie KALFON

Agnès MACE

The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure.

In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.

Chronic myeloid leukemia (CML) is a clonal myeloproliferative syndrome with an estimated incidence of 0.8-1 cases per 100,000 person-years in 2018 in France. CML is characterized by the transformation of a pluripotent stem cell resulting in an increase in myeloid and erythroid lineages and megakaryocytes in peripheral blood as well as myeloid hyperplasia in the bone marrow.

In the absence of treatment, the disease, which begins in a chronic phase over a few years, progresses to an acceleration phase, before reaching an acute phase, known as a blast crisis, with a poor prognosis. This abnormal proliferation of white blood cells results from the reciprocal translocation (exchange) between chromosomes 9 and 22. This exchange brings two normally distinct genes into contact: the (breakpoint cluster region) BCR gene and the abl gene (Tyrosine-protein kinase), which will form an abnormal gene called "fusion Bcr-abl". This gene encodes a fusion protein with deregulated tyrosine kinase activity that activates various mechanisms involved in cell multiplication.

Since the 1990s, the arrival of the first tyrosine kinase inhibitor (TKI), imatinib, has radically changed patient management. Indeed, according to Public Health France, this treatment has allowed the majority of patients to remain in the chronic phase for a long time. Patient survival has therefore increased dramatically as the life expectancy of patients with CML taking their treatment regularly approaches that of the general population.

However, even though several generations of TKI have been developed, certain toxicities may lead to discontinuation of treatment, or to a modification of the dose. Indeed, a meta-analysis published in June 2020 shows that second and third generation of TKI improve the major molecular response by 3 months, but are associated with a recrudescence of thrombocytopenia, cardiovascular, pancreatic and hepatic events. First generation imatinib therefore remains the best option for patients with co-morbidities despite the frequent presence of headaches, digestive disorders, and cramps.

It has therefore always been customary to change the TKI or modify the prescribed doses, while the side effects or ineffectiveness of these inhibitors could be explained by drug interactions, or be related to the use of herbal medicine. Indeed, TKIs are metabolized by the cytochrome P450 system. The activity of this cytochrome is not only different from one person to another, but can also be affected by other treatments. For example, some treatments will inhibit the activity of this cytochrome P450, increasing the exposure of TKIs in plasma. The pharmacokinetics of the drug will therefore depend on these concomitant treatments and their influence, among others, on cytochrome P450.

In addition, the median age at diagnosis is respectively 61 years for men and 62 years for women. These patients are therefore often carriers of other chronic diseases and are have multiple treatments.

Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia

Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia: PHARM-LMC Study

Number of patients for whom pharmaceutical interventions have been done secondly to pharmaceutical conciliation will be reported.

Molecular response will be reported via BCR-ABL transcript rate measured by quantitative polymerase chain reaction (qPCR) or digital polymerase chain reaction (PCR).

Concomitant treatments will be reported during 12 months.

Observance to Tyrosine kinase inhibitor will be measured with Girerd Questionnaire.

Number and description of sides effects will be reported.

Patients' satisfaction will be measured with a visual scale from 0 to 10.

Patients' quality of life will be measured with the Quality of Life questionnaires (QLQ-C30) questionnaire. The maximum score is 126, the minimum score is 30. More the score is, worst the health state is.

Institut de Cancérologie de la Loire

Centre Hospitalier Universitaire de Saint Etienne

Paul Gougis, MD

Olivier Mir, MD-PhD

The use of phytotherapies or specific food or dietary supplement (HFDS) is common among cancer patients. They can also be responsible of clinically relevant interaction with anti-cancer treatments. This study aims at assessing the proportion patients using HFDS which are likely to have an interaction with their anticancer treatments. The data is collected through a smartphone/tablet application. The aim of the study is to demonstrate that clinically significant herb-drug interaction with anticancer treatment could be avoid using these devices.

The use of herbal treatment, also called phytotherapies, or dietary supplements or specific food (herbs, food or dietary supplements HFDS) is very common and have been evaluated between 30 and 70%, depending on the population and the studies.However, few studies have been made to evaluate the risk of interaction with oncology treatment in real life. Some interaction are very well known by both patients and clinicians, like the inhibition of the cytochrome 3A4 by grapefruit or the induction of the CYP3A4 by Saint John's Wort. However, many other interactions have been demonstrated, like the inhibition of the CYP3A4 by goldenseal extracts (among many others) although this is frequently used phytotherapy, both over the counter or "prescribed" by herb specialists.

This study aims at demonstrating that a smartphone or tablet application could be used to prevent significant interaction between phytotherapy or food or dietary supplements with anticancer treatments.

The application is used to collect data prospectively that will be analysed for interaction retrospectively. The interactions between phytotherapy have been classified in 4 categories :

* likely (clinically relevant data in the literature between the herb and the anticancer treatment either directly or through documented CYP interaction)
* possible (animal model or in vitro data in favor of an interaction)
* unlikely (clinical data or animal model or in vitro data in favor of no interaction)
* unknown (no data available or data from that could not allow a conclusion due to its poor quality or an ambiguous conclusion) The investigators aim at measuring the proportion of "likely" herb-drug interaction (or dietary supplement or food) in a population of patients followed and treated for a cancer, either local or metastatic.

The investigators also aim at characterizing the population, quantifying the proportion of patients taking HFDS and, to measure the proportion of "possible" herb-drug interaction.

PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy

Measure of the rate of patients having a consumption of at least 1 phytotherapy, aspecific food (which is a specific ingredient that is eaten daily, like daily consumption of grapefruit juice or green tea) or a dietary supplement and having a likely interaction (justified through a clinically proven cytochrome interaction or direct interaction) with their anticancer treatment. The interaction could be through an inhibition of a major CYP in the metabolism of the chemotherapy. Each potential interaction will be searched in the literature.

Anticancer treatments include chemotherapy, targeted therapies, hormonotherapies, radiotherapy or surgery.

Paul Gougis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer	NCT01066741	Oropharynx Canc... Hypopharynx Can...	Homeodent® 1.4% Sodium Bic...	18 Years - 85 Years	Centre Leon Berard
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer	NCT00160901	Breast Cancer	two complex nat...	18 Years - 75 Years	Heidelberg University
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer	NCT00160901	Breast Cancer	two complex nat...	18 Years - 75 Years	Heidelberg University
Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia	NCT05130138	Chronic Myeloid...	Pharmaceutical ...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer	NCT00160901	Breast Cancer	two complex nat...	18 Years - 75 Years	Heidelberg University
PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy	NCT04128865	Cancer		18 Years -	Groupe Hospitalier Pitie-Salpetriere
Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia	NCT05130138	Chronic Myeloid...	Pharmaceutical ...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer	NCT01066741	Oropharynx Canc... Hypopharynx Can...	Homeodent® 1.4% Sodium Bic...	18 Years - 85 Years	Centre Leon Berard

Spots Global Cancer Trial Database for phytotherapy

Every month we try and update this database with for phytotherapy cancer trials from around the world to help patients and their families find trials that might be right for them.
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