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

Phase 1

• Conditions: Primary diagnosis of breast cancer (stage: I-III A) treated with adjuvant chemotherapy and / or endocrine therapy after surgical treatment.; MedDRA version: 20.0Level: SOCClassification code 10038604Term: Reproductive system and breast disordersSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003176-40-IT
• Lead Sponsor: AZIENDA USL TOSCANA NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 320

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified