The FASTEX trial: Fasting mimicking diet and exercise medicine as adjuvant therapies in the treatment of patients with breast cancer. - Trial ANZCTR12623000996662

Timeline & Enrollment

Primary Outcome

Pathologic stage after neoadjuvant chemotherapy: it will be assessed at the completion of chemotherapy, following surgical resection, according to the American Joint Committee on Cancer (AJCC) system. The pathologic complete response (pCR) will be determined by a pathologist following examination of tissue (breast and nodes) removed at the time of surgery. Moreover, a four-point Residual Cancer Burden (RCB) index will be also assessed from routine pathologic sections to report the pathological outcome.

Summary

This study will evaluate the effects of a fasting mimicking diet or an exercise program on tumour response to neoadjuvant chemotherapy (chemotherapy prior to surgery) in breast cancer patients compared to a group of patients undergoing neoadjuvant chemotherapy without following a diet or exercise program. Who is it for? You may be eligible for this study if you are an adult woman aged 18 years or older, you have been diagnosed with breast cancer and you are scheduled to undergo chemotherapy prior to surgery to remove cancerous tissue. Study details Participants who choose to enrol in this study will be offered to join one of three groups. Participants who choose to join the first group will be given a prescribed diet that is designed to mimic a fasting diet. The diet will be low calorie and low protein, participants will be asked to follow the diet 2 days before their chemotherapy infusion and continue it for 2 days after their infusion. Participants will then return to their usual diet until 2 days prior to their next infusion. Participants who choose to join the second group will be asked to attend a gym 2 or 3 days per week to complete supervised exercise routines. During weeks where participants are undergoing chemotherapy they will attend 2 sessions/week for 50-60 min per session. During the weeks without chemotherapy treatment, patients will attend 3 sessions/week for 50-60 min per session. Participants who do not wish to participate in either the diet or exercise groups may also enrol in this study and complete blood tests and questionnaires prior to and after completing their chemotherapy. These participants will act as the comparator group to determine if either the diet or exercise program has any effect on the cancer cells compared to chemotherapy alone. It is hoped this research will provide preliminary evidence as to whether following a fasting mimicking diet or an exercise program while undergoing chemotherapy for breast cancer is able to slow the spread of cancer cells compared to chemotherapy alone. If either the diet or exercise program is shown to have a beneficial effect on breast cancer patients, a larger randomised clinical trial of one or both of these treatments may be undertaken

ICD-10 Classifications