Clinical Trials Register

Summary
EudraCT Number:	2020-003176-40
Sponsor's Protocol Code Number:	CHEMOCIM
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-02-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-003176-40

A.3

Full title of the trial

Randomised, clinical trial, controlled, open-label, multicenter, non-profit study to evaluate the superiority of a complementary treatment with additional Homeopathic Medicines and Acupuncture / Auriculotherapy compared to an active control group with only Cognitive Rehabilitation and Nutritional Advice.

Studio clinico, controllato, randomizzato, in aperto, multicentrico, no-profit, per valutare la superiorità di un trattamento complementare con Medicinali Omeopatici e Agopuntura/Auricoloterapia addizionali rispetto ad un gruppo di controllo attivo con sola Riabilitazione Cognitiva e Consigli Nutrizionali.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Assessment of anticancer therapy-related cognitive impairment in breast cancer patients and evaluation of integrated therapy effects with rehabilitation exercises, diet and add-on complementary medicine

Valutazione del deterioramento cognitivo correlato alla terapia antitumorale nei pazienti con carcinoma mammario e valutazione degli effetti della terapia integrata con esercizi di riabilitazione, dieta e medicina complementare aggiuntiva

A.3.2

Name or abbreviated title of the trial where available

CHEMOCIM

A.4.1

Sponsor's protocol code number

CHEMOCIM

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA USL TOSCANA NORD OVEST
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Regione Toscana (Bando Ricerca Salute 2018 per la ricerca indipendente)
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda USL Toscana Nord Ovest
B.5.2	Functional name of contact point	Task Force Sperimentazioni Clinche
B.5.3	Address:
B.5.3.1	Street Address	viale Alfieri, 36
B.5.3.2	Town/ city	Livorno
B.5.3.3	Post code	57124
B.5.3.4	Country	Italy
B.5.6	E-mail	sperimentazioni.cliniche@uslnordovest.toscana.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	GUNA BDNF 4CH 30ML GTT
D.2.1.1.2	Name of the Marketing Authorisation holder	Guna Spa
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Brain-Derived Neuritrophic Factor
D.3.2	Product code	[801846116]
D.3.4	Pharmaceutical form	Oral drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Brain-Derived Neuritrophic Factor
D.3.9.3	Other descriptive name	Brain-Derived Neuritrophic Factor
D.3.10	Strength
D.3.10.1	Concentration unit	DF dosage form
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Yes
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PHOSPHORUS 30CH GR
D.2.1.1.2	Name of the Marketing Authorisation holder	Boiron Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PHOSPHORUS 30CH
D.3.2	Product code	[800024224]
D.3.4	Pharmaceutical form	Pillules
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	PHOSPHORUS
D.3.9.3	Other descriptive name	FOSFORO BIANCO
D.3.10	Strength
D.3.10.1	Concentration unit	DF dosage form
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Yes
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary diagnosis of breast cancer (stage: I-III A) treated with adjuvant chemotherapy and / or endocrine therapy after surgical treatment.

Diagnosi primaria di cancro alla mammella (stadio: I-III A) trattato con chemioterapia adiuvante e/o terapia endocrina dopo il trattamento chirurgico.

E.1.1.1

Medical condition in easily understood language

Breast cancer operated and treated with chemotherapy and / or hormone therapy

Tumore alla mammella operato e trattato con chemioterapia e/o ormonoterapia

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10038604
E.1.2	Term	Reproductive system and breast disorders
E.1.2	System Organ Class	10038604 - Reproductive system and breast disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the effectiveness of an integrated medicine treatment (Aug / Omeo / Ago + Omeo) additional to the only standard treatment on cognitive disorders in patients with breast cancer.

Confrontare l’efficacia di un trattamento di Medicina Integrata (Ago/Omeo/Ago+Omeo) aggiuntivo rispetto al solo trattamento standard sui disturbi cognitivi in pazienti affette da carcinoma mammario.

E.2.2

Secondary objectives of the trial

a) Assess the possible effect, and the relative influence, of anxiety and mood in cognitive disorders through self-administered questionnaires;
b) Measure the serum levels of brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha at the base-line and 10 months after enrollment and start of therapy;
c) Evaluate any changes in the quality of life at the base-line and after 6 months and 11 months in all arms of the study;
d) Measure cognitive deficits with in-depth psychometric tests at the baseline and at the 11th month in all the arms of the study.

a) Valutare l’eventuale effetto, e la relativa influenza, dell’ansia e del tono dell’umore sui disturbi cognitivi tramite questionari autosomministrati;
b) Misurare i livelli sierici di brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha alla base-line e a 10 mesi dall’arruolamento e inizio della terapia;
c) Valutare eventuali variazioni nella qualità di vita alla base-line e dopo 6 mesi e 11 mesi in tutti i bracci dello studio;
d) Misurare i deficit cognitivi con test psicometrici approfonditi alla baseline e all’11° mese in tutti i Bracci dello studio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Aged between 18 and 65;
Breast cancer diagnosis (stage: I-III A) within 12 months of enrollment;
Standard dose adjuvant chemotherapy for at least 3-6 months and concluded for at least 2 months and / or endocrine therapy in progress for at least 6 months;
Signature of Informed Consent.

Età compresa tra 18 e 65 anni;
Diagnosi di tumore alla mammella (stadio: I-III A) entro 12 mesi dall’arruolamento;
Chemioterapia adiuvante a dose standard per almeno 3-6 mesi e conclusa da almeno 2 mesi e/o terapia endocrina in corso da almeno 6 mesi;
Firma del Consenso Informato.

E.4

Principal exclusion criteria

Known metastatic tumor;
History of previous severe neurological or psychiatric disorders (Epilepsy, MCI, Dementia, Psychosis, etc.);
Positive history of oncological pathology within 5 years from the date of enrollment;
Family history of past neurological or psychiatric disorders;
Concomitant therapies with psychoactive drugs;
Severe needle phobia.

Tumore in fase metastatica nota;
Anamnesi di disturbi neurologici o psichiatrici pregressi di grado severo (Epilessia, MCI, Demenza, Psicosi, etc.);
Anamnesi positiva per patologia oncologica entro 5 anni dalla data dell’arruolamento;
Anamnesi famigliare di disturbi neurologici o psichiatrici pregressi;
Terapie concomitanti con farmaci psicoattivi;
Grave fobia degli aghi.

E.5 End points

E.5.1

Primary end point(s)

1. the self-administered questionnaire on subjectively perceived cognitive symptoms (FACT-Cog) at baseline, at 6 months and after 11 months in all arms of the study;
2. psychometric tests (Brief Cognitive State Exam -EBSC-, Frontal Assessment Battery -FAB-, Phonemic Fluences, London Tower Test, Brixton Anticipation Test, Subtest Similarities and Reasoning for Matrices -WAIS-IV-, Subtest Search for Symbols and Cipher and related calculation of the Processing Speed ¿¿Index -WAIS-IV-, Digit Memory subtest -WAIS-IV-, Symbols Span subtest -WMS-IV-, Logical Memory subtest I-II, Learning of Pairs of Words I-II and Visual Reproduction I-II -WMS-IV-, Attentional Matrices, Stroop Test, Trail Making Test AB) at baseline, at 3 months, at 6 months and after 11 months in all arms of the study (Evaluations Long and Short Intermediate NPS).

1. il questionario autosomministrato sulla sintomatologia cognitiva soggettivamente percepita (FACT-Cog) alla baseline, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio;
2. i test psicometrici (Esame Breve Dello Stato Cognitivo -EBSC-, Frontal Assessment Battery -FAB-, Fluenze Fonemiche, Test delle Torri di Londra, Brixton Anticipation Test, subtest Somiglianze e Ragionamento per Matrici -WAIS-IV-, subtest Ricerca di Simboli e Cifrario e relativo calcolo dell’Indice di Velocità di Elaborazione -WAIS-IV-, subtest Memoria di Cifre -WAIS-IV-, subtest Span di Simboli -WMS-IV-, subtest Memoria Logica I-II, Apprendimento di Coppie di Parole I-II e Riproduzione Visiva I-II -WMS-IV-, Matrici Attenzionali, Test di Stroop, Trail Making Test A-B) alla baseline, a 3 mesi, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio (Valutazioni NPS Lunghe e Brevi Intermedie).

E.5.1.1

Timepoint(s) of evaluation of this end point

1. at baseline, at 6 months and after 11 months in all arms of the study;
2. at baseline, at 3 months, at 6 months and after 11 months in all arms of the study (Evaluations Long and Short Intermediate NPS).

1. alla baseline, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio;
2. alla baseline, a 3 mesi, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio (Valutazioni NPS Lunghe e Brevi Intermedie).

E.5.2

Secondary end point(s)

Assess the possible effect, and the relative influence, of anxiety and mood tone on cognitive anxiety disorders and mood tone on cognitive disorders through self-administered questionnaires (STAI and HADS); Measure serum brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha levels; Measure any changes in Quality of Life using the self-administered FACT-G and FBSI questionnaires

Valutare l’eventuale effetto, e la relativa influenza, dell’ansia e del tono dell’umore sui disturbi cognitivi dell’ansia e del tono dell’umore sui disturbi cognitivi tramite questionari autosomministrati (STAI e HADS); II. Misurare i livelli sierici di brain-derived neurotrophic factor (BDNF), IL 6 and TNF alpha; Misurare eventuali variazioni nella Qualità di Vita tramite i questionari autosomministrati FACT-G e FBSI

E.5.2.1

Timepoint(s) of evaluation of this end point

At the base-line; At the base-line and 6 months after enrollment and start of therapy; At baseline, at 6 months and after 11 months in all arms of the study using the self-administered FACT-G and FBSI questionnaires;

Basale; Alla base-line e a 6 mesi dall’arruolamento e inizio della terapia; Alla baseline, a 6 mesi e dopo 11 mesi in tutti i bracci dello studio tramite i questionari autosomministrati FACT-G e FBSI;

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Riabilitazione Cognitiva e Consigli Nutrizionali

Cognitive rehabilitation and nutritional advice.

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Overall, the conclusion of the study is set for the 30th month from the start of the project (3 November 2022).

Complessivamente la conclusione dello studio è fissata al 30° mese dall’inizio del progetto (3 Novembre 2022).

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

320

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

320

F.4.2

For a multinational trial

F.4.2.1

In the EEA

320

F.4.2.2

In the whole clinical trial

320

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not defined

Non definiti

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-02-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-23

P. End of Trial
P.	End of Trial Status	Ongoing

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