LBA94 - Effects of short-term fasting on quality of life as an add-on option during chemotherapy

Background

Growing pre- and clinical evidence show that short-term fasting (STF) of 48 to 72 hours around each chemotherapy (CTX) may potentially support CTX, reducing toxicity and adverse effects.

Methods

This randomised multi-center study of breast cancer (BC) patients undergoing CTX was conducted to assess feasibility and health-related quality of life (HRQoL) for 60-72 h STF compared to a plant-based low-sugar diet (PBD). HRQoL was assessed by FACT-G, FACIT-F (fatique) and further questionnaires at baseline (V0) and after each CTX session (day 7) as well as after 4 (V1) and 6 (V2) months. Laboratory parameters were collected at the same time points. CTX consisted of 4 x AC or EC, followed by either 12 x paclitaxel (Pac) (80 mg/m²) weekly or 4 x docetaxel (Doc) three-weekly (100 mg/m²).

Results

106 patients were included in the study and randomized to STF (n=52) or PBD (n=56). 90 (84.9%) patients obtained AC/EC -> Pac and 16 (15.1%) AC/EC -> Doc. The 27-item generic CORE questionnaire FACT-G measuring four domains of HRQoL (physical, social/family, emotional, and functional well-being) showed no significant difference at V0 (STF 82.9; PBD 81.9; p=0.523). STF-patients' FACT-G improved at day 7 from cycle to cycle versus PBD-patients. At cycle 4, day 7, FACT-G for STF was 78.3 (std. error (SE) 2.7; 95% C.I. 72.8-83.7) and for PBD 69.3 (SE 2.6: 95% C.I. 64.0-74.6). The difference 9.0 (SE 3.8) was statistically significant (p = 0.021) and clinically relevant (9.0 > minimal important difference (MID = 5)). The differences between the corresponding FACIT-F Trial Outcome Index resp. Total FACIT-F at cycle 4 day 7 were 13.1 (SE 4.7) resp. 15.8 (SE 5.6), both in favor of STF (> MID= 6, p < 0.007). The mean Total Hospital Anxiety and Depression Score (HADS-T) shows mental distress (HADS-T ≥ 13) for both STF and PBD at V0 and cycle 4 day 7 with no statistically significant differences. At V0 mean platelet counts (MPCs) were 256.6 (SE 10.8) for STF and 266.2 (SE 9.9) for PBD (p=0.512). At cycle 4 day 7 MPCs were 209.5 (SE 13.7) for STF and 177.7 (SE 12.3) for PBD.

Conclusions

Neither STF nor PBD showed serious adverse effects in the studied population. STF during chemotherapy is well tolerated and appears to improve QoL and fatigue during chemotherapy compared to a plant-based low-sugar diet.

Clinical trial identification

NCT03162289 on 22 May 2017.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

This study is funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich, Switzerland).

Disclosure

D.A. Koppold: Financial Interests, Personal, Ownership Interest: Academy for Integrative Fasting (AIF) GbR; Financial Interests, Personal, Advisory Role: Fastic (Mobile App); Financial Interests, Personal, Leadership Role: ÄGHE (Ärztegesellschaft Heilfasten und Ernährung e.V.). C. Kessler: Financial Interests, Personal, Advisory Board: Bruno Zimmer. E. Hanslian: Non-Financial Interests, Personal, Leadership Role: ÄGHE (Ärztegesellschaft Heilfasten und Ernährung e.V.)). A. Michalsen: Financial Interests, Personal, Ownership Interest: Academy for Integrative Fasting (AIF) GbR, Salufast GmbH; Non-Financial Interests, Personal, Leadership Role: ÄGHE (Ärztegesellschaft Heilfasten und Ernährung e.V.). All other authors have declared no conflicts of interest.