Body weight change in a medical supplement group in patients with early breast cancer during chemotherapy: a randomized, controlled trial.

Background: Patients with early-stage breast cancer usually receive anthracycline-based chemotherapy, known for its adverse effects such as neutropenia, nausea, and vomiting, which can result in a state of malnutrition. This study aimed to evaluate the efficacy of the use of oral nutritional support (ONS) in terms of body weight (BW), nutritional status, and quality of life (QOL) in patients with early-stage breast cancer receiving doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m² for four cycles (4AC).

Methods: Patients with early-stage breast cancer scheduled to undergo 4AC were randomly assigned in a 1:1 ratio to receive either ONS or dietary counseling as the standard of care (SOC). ONS provided 460 kcal and 17.1 g of protein per day over a 12-week period. BW at baseline and week 12 were measured, while QOL and nutritional status were evaluated at baseline and week 12 using the EORTC QLQ-C30 questionnaire and Patient-Generated Subjective Global Assessment. Complete blood count was performed every 3 weeks.

Results: A total of 40 patients were enrolled. At baseline, most were in the normal weight to obese BMI range and were well-nourished. At week 12, patients in the ONS group had BW of 65.8 kg, which was 5.7 kg higher than that of their counterparts in the SOC group; however, the difference was not statistically significant (p = 0.167). Patients in the ONS group had a statistically significant increase in BW from 63.4 to 65.8 kg, (p = 0.004), while those in the SOC group had a non-significant increase from 59.6 to 60.1 kg, (p = 0.54). Patients in the SOC group experienced a statistically significant decline to being moderately malnourished, whereas their ONS counterparts did not. The QOL of global health status and function scales was maintained in both groups. Only appetite loss showed a statistically significant decline (in the SOC group). The mean absolute neutrophil count levels of patients in the ONS group tended to be higher than those in the SOC group at week 9; however, this difference was not statistically significant (p = 0.09).

Conclusion: The consumption of ONS in addition to dietary counseling, in patients with early-stage breast cancer undergoing anthracycline-based chemotherapy, is associated with an increase in final body weight at 12 weeks compared to baseline body weight. ONS is also associated with less significant weight loss and a slower deterioration of nutritional status in patients during chemotherapy in the short term. ONS should be considered to incorporate into dietary counseling for patients with early-stage breast cancer receiving an anthracycline-based regimen, especially for those at risk of malnutrition, such as those with low baseline body weight, or loss of appetite.

Trial registration: Clinical trial registration number: NCT06311357 . Date: 13 March 2024.