Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Peri-chemotherapy intermittent fasting: Structured 24 hour fast administered with each cycle of neoadjuvant chemotherapy. Fasting begins 18 hours before the scheduled chemotherapy infus
Sponsors
Basavatarakam Indo American Cancer Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed invasive triple negative breast cancer with estrogen receptor less than 1 percent, progesterone receptor less than 1 percent, and HER2 negative defined as immunohistochemistry 0 or 1 plus, or HER2 non amplified by in situ hybridization. 2. Clinical stage I to III disease planned to receive standard neoadjuvant chemotherapy with curative intent. 3. Age 18 years or older. 4. Eastern Cooperative Oncology Group performance status 0 or 1. 5. Body mass index 18.5 kg per square meter or greater at baseline. 6. Adequate hematological, renal, and hepatic function according to institutional eligibility criteria for neoadjuvant chemotherapy. 7. Ability to consume oral diet and comply with the prescribed fasting schedule. 8. Nutritional screening demonstrating absence of moderate or severe malnutrition as determined by the institutional nutritional assessment protocol. Willing and able to provide written informed consent and comply with study procedures. No prior systemic therapy for the current breast cancer diagnosis. Planned to receive treatment and follow up at the study institution. Women of childbearing potential must have a negative pregnancy test before enrolment and agree to use effective contraception during study participation. Comments
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus requiring pharmacological treatment, including insulin or oral hypoglycemic agents. 2. History of type 1 diabetes mellitus. 3. History of eating disorders including anorexia nervosa, bulimia nervosa, binge eating disorder, or other clinically significant eating disorders. 4. Body mass index less than 18.5 kgp per square meter. 5. Moderate or severe malnutrition as determined by institutional nutritional screening. 6. Pregnancy or breastfeeding. 7. History of recurrent hypoglycemia, documented fasting intolerance, or medical conditions associated with inability to safely fast. 8. Severe uncontrolled cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disease considered by the investigator to make fasting unsafe. 9. Active uncontrolled infection or any serious concurrent illness that may interfere with study participation. 10. Current use of medications requiring regular food intake or considered incompatible with intermittent fasting, including insulin and sulfonylureas. 11. Inability to consume an oral diet or gastrointestinal disorders likely to impair nutritional intake. 12. Prior systemic therapy, radiotherapy, or surgery for the current breast cancer before enrolment. 13. Participation in another interventional clinical trial that may interfere with study outcomes. 14. Any psychiatric illness, cognitive impairment, or social circumstance that, in the opinion of the investigator, would limit compliance with study procedures. 15. Any other condition that, in the opinion of the investigator, makes participation unsafe or not in the best interest of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite feasibility of fasting intervention Components 1. Recruitment: at least 30 percent of eligible patients consent. 2. Fasting adherence: at least 75 percent of enrolled patients complete the fasting protocol during at least 4 chemotherapy cycles. 3. Acceptability: more than 70 percent rate the intervention acceptable. 4. Safety: No more than 1 Grade 3 fasting related adverse event. Feasible 4 criteria achieved. Feasible with modification 3 criteria achieved. Timepoint: From enrolment until completion of chemotherapy, approximately 20 to 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate, defined as absence of residual invasive carcinoma in breast and axillary lymph nodes ypT0is and ypN0 per CTNeoBC criteria on surgical resection specimen expressed as proportion with 95 percent exact Clopper Pearson confidence interval, descriptive comparison between Arm A and Arm B, non randomisedTimepoint: Surgical resection specimen assessment, approximately 24 to 28 weeks from enrolment.;Residual Cancer Burden, RCB index continuous and RCB class 0 to III calculated using MD Anderson RCB calculator for patients not achieving pCR. Timepoint: Surgical resection specimen assessment, approximately 24 to 28 weeks from enrolment.;Relative Dose Intensity, RDI defined as the ratio of actual cumulative chemotherapy dose delivered to planned cumulative dose, expressed as a percentage, calculated per individual chemotherapy agent and as a composite across the full neoadjuvant regimen. Dose delays, reductions, and omissions recorded per cycle with reason categorised as, haematological toxicity, non-haematological toxicity, fasting related, patient preference, or other. Proportion of patients with composite RDI below 85 percent for any agent reported as a clinically significant dose attenuation threshold. Descriptive comparison between Arm A and Arm B.Timepoint: Calculated at completion of all planned neoadjuvant chemotherapy cycles, approximately 20 to 24 weeks from enrolment.;Body Weight and Nutritional Status Change in body weight from baseline expressed as percentage weight change at each assessment timepoint. Proportion of patients experiencing clinically significant weight loss defined as greater than 5 percent reduction from baseline body weight at any assessment, triggering mandatory dietetic review per protocol. Additional nutritional parameters: BMI, Malnutrition Universal Screening Tool score, serum albumin, and C-reactive protein as a composite nutritional and inflammatory index. All parameters reported as mean with standard dev | — |
Countries
India
Contacts
Public ContactDr Rakesh Pinninti
Basavatarakam Indo-American Cancer Hospital and Research Institute
Outcome results
None listed