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

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. - CHEMOCIM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003176-40-IT

Enrollment

320

Registered

2021-02-10

Start date

2021-02-23

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary diagnosis of breast cancer (stage: I-III A) treated with adjuvant chemotherapy and / or endocrine therapy after surgical treatment. MedDRA version: 20.0 Level: SOC Classification code 10038604 Term: Reproductive system and breast disorders System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: GUNA BDNF 4CH 30ML GTT Product Name: Brain-Derived Neuritrophic Factor Product Code: [801846116] Pharmaceutical Form: Oral drops Current Sponsor code: Brain-Derived Neuritrophic Factor Oth

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;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).;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).	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;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).;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).

—

Secondary

Measure	Time frame
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;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;	—

Measure

Time frame

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;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;

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Countries

Italy

Contacts

Public ContactTask Force Sperimentazioni Clinche

Azienda USL Toscana Nord Ovest

sperimentazioni.cliniche@uslnordovest.toscana.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026