Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer

NCT07884721 | Not Yet Recruiting DMC

• 2 other identifiers: FASTEN-012025-A02737-42
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 7

Brief Summary

This randomized, multicenter, open-label clinical study will evaluate whether adding the Fasten Onco digital therapy, which supports a fasting-mimicking diet (FMD), to standard neoadjuvant treatment can reduce treatment-related fatigue in adult women with stage II or III triple-negative breast cancer. Participants will be randomly assigned to receive either standard neoadjuvant treatment alone or standard neoadjuvant treatment together with the Fasten Onco program. Participants assigned to Fasten Onco will follow a short fasting-mimicking diet around treatment cycles, supported by the Fasten Onco digital application and under medical supervision. The main objective is to compare fatigue between the two groups during neoadjuvant treatment. The study will also assess quality of life, treatment-related side effects, pathological response to treatment, and participants' adherence to and satisfaction with the Fasten Onco program.

Conditions

Triple-Negative Breast Cancer (TNBC)

Keywords

Neoadjuvant Treatment; Fasting-Mimicking Diet; Digital Therapeutics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in FACIT-Fatigue Total Score

  Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score. The FACIT-Fatigue is a 13-item questionnaire assessing fatigue and its impact on daily activities and functioning. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. The primary comparison will assess the difference in change from baseline between the FASTEN Group and the Standard of Care Group.

  Baseline to Day 7 after initiation of Cycle 8 of neoadjuvant treatment

Secondary Outcomes (26)

• Change From Baseline in FACIT-Fatigue Total Score and Subscores Over the Neoadjuvant Treatment Period

  Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks

• Time to Definitive Fatigue Worsening

  From randomization through study completion, up to 3 years

• FACIT-Fatigue Severity Category

  Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks

• Change From Baseline in FACT-G Total Score at Cycle 8

  Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks

• Change From Baseline in FACT-G Total Score Over the Neoadjuvant Treatment Period

  Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks

Other Outcomes (13)

• Dose Intensity of Neoadjuvant Treatment

  From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks

• Number of Neoadjuvant Treatment Cycles Received

  From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks

• Number of Neoadjuvant Treatment Dose Delays

  From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks

Study Arms (2)

FASTEN Group

EXPERIMENTAL

Participants receive standard neoadjuvant treatment plus the Fasten Onco digital therapy integrating a fasting-mimicking diet (FMD). The FMD program is synchronized with neoadjuvant treatment cycles and is supported by the Fasten Onco digital application under medical supervision.

Device: Fasten Onco

Standard of Care Group

ACTIVE COMPARATOR

Participants receive standard neoadjuvant treatment alone, without the Fasten Onco digital therapy or the fasting-mimicking diet (FMD) intervention.

Drug: Standard Neoadjuvant Treatment

Interventions

Standard Neoadjuvant Treatment DRUG

Standard neoadjuvant treatment for stage II/III triple-negative breast cancer according to the standard of care at each participating center. Treatment may include paclitaxel, carboplatin, epirubicin or doxorubicin, cyclophosphamide, and pembrolizumab, used within their approved indications. Standard neoadjuvant treatment is administered in both study groups.

Standard of Care Group

Fasten Onco DEVICE

Fasten Onco is a digital medical device designed to support the implementation of a fasting-mimicking diet (FMD) during neoadjuvant treatment. The device provides a personalized nutritional program synchronized with the participant's treatment schedule, together with educational content, reminders, and guidance to support adherence. The program is prescribed and configured by a healthcare professional and is used under medical supervision.

FASTEN Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patient has provided written informed consent before participating in the trial.
• Women aged ≥18 years.
• Patient with documented diagnosis of stage II/III triple negative breast cancer (TNBC) as per ESMO guidelines.
• Patient with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Patient has adequate bone marrow function.
• Patient has adequate renal function.
• Patient has adequate liver function.
• Patient has adequate heart function, i.e., no signs of heart failure or clinically significant arrhythmia.
• Patient has completed the FACIT-Fatigue and FACT-G questionnaires at baseline.
• Patient has access to a smart phone with access to the internet.
• Patient with a weighing scale to measure weight.
• Patient is able and willing to complete the trial, including the assigned questionnaires.
• Patient can read and write in French.
• Patient is covered by the French social security insurance or a similar healthcare insurance.

You may not qualify if:

• Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (covering all protected persons: pregnant women, women in labour, breastfeeding mothers, persons deprived of their liberty by judicial or administrative order, minors, and persons subject to a legal protection measure: guardianship or curatorship).
• Patient with prior breast cancer (invasive or non-invasive breast cancer).
• Patient with a history of cancer within the last 5 years, except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
• Patient diagnosed with type I or II diabetes and treated.
• Patient with a body mass index (BMI) \<18.5 kg/m² or patients with a BMI between 18.5 kg/m² and 20 kg/m² and weight loss ≥5% in the last 3 months or if a BMI \>20 kg/m² and weight loss \>10% in last 3 months.
• Patient with food allergies.
• Patient with metabolic disorders affecting gluconeogenesis or adaptation to short periods of fasting.
• Patient already treated with a chronic immunosuppressive drug (dexamethasone used according to SOC is permitted) \>10 mg per day of prednisone or equivalent at study entry.
• Previous episodes of symptomatic hypotension leading to loss of consciousness.
• Previous episodes of symptomatic hypoglycemia.
• Patient with behavioral eating disorders.
• Patient already following a fasting or fasting mimicking diet.
• Use of herbal preparations or medications interfering with chemoimmunotherapy pharmacokinetics: St. John's wort, kava, ephedra (ma huang), gingko biloba, aloe vera (and its derivatives), artemisinin (and its derivatives), and dehydroepiandrosterone (DHEA).
• Use of vitamins or food supplements exceeding one-tenth (1/10) of the daily recommended dose except for vitamin D or containing calories.
• Use of any supplement or product with unknown chemical composition.

Sponsors & Collaborators

• FASTEN: lead

Study Sites (7)

Hôpital Privé de Provence

Aix-en-Provence, 13080, France

Location

Centre Hospitalier de Bligny

Briis-sous-Forges, 91640, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, 92200, France

Location

Clinique Saint Jean de Dieu

Paris, 75007, France

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lorène Seguin, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Grojean, PhD

CONTACT

+33786680521.; sgrojean@fondation-force.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)