Abstract 1679P
Background
Cancer anorexia-cachexia syndrome (CAS) is a significant comorbidity in all cancer patients that increase the mortality rate. Almost all head and neck cancer (HNC) patients suffered from this syndrome. CAS causes increased energy expenditure by increased systemic inflammation and decreased energy consumption due to anorexia. This leads to skeleton muscle breakdown and affects the quality of life. Nutritional interventions and cancer treatment are the mainstays to treat this situation. However, a vicious cycle causes CAS to persist, especially in HNC, where tumor location and its treatment interfere with nutritional intervention. Curcumin shows the effect of anti-inflammatory effects, including modulated CAS in animal and in vitro studies.
Methods
This is a randomized, double-blind, placebo-controlled phase IIa study. 20 patients with CAS in locally advanced or advanced HNC adequately fed via a feeding tube were enrolled and randomized in 1:1 to receive oral curcumin (at a dose of 4000 mg daily) or placebo for 8 weeks. The primary endpoint was body composition (muscle mass, body fat mass, basal metabolic rate; BMR). The secondary endpoints were handgrip strength, BMI, absolute lymphocyte count (ALC), safety, and toxicity.
Results
There is a statistically significant benefit from curcumin on improvement of muscle mass compared to placebo (2.16% [95% CI, -0.75 to 5.07] vs -3.82% [95% CI, -8.2 to 0.57]; P = 0.019). The other parameters of body compositions are not statiscally significant but tend to favor curcumin benefit. The body fat mass (-0.51 [95% CI, -21.89 to 20.86] vs -8.97% [95% CI, -19.43 to 1.49]; P = 0.432) and the BMR (0.54% [95% CI, -1.6 to 2.67] vs -1.61% [95% CI, -4.05 to 0.84]; P = 0.153). Notably, patients with curcumin showed less reduction in handgrip strength and ALC but this was not statiscally significant. Most adverse events were grade 1 in both groups similarly.
Conclusions
The curcumin add-on resulted in a significant increase in muscle mass over standard nutritional support. Furthermore, it may improve and delay a decrease in the other body compositions, handgrip strength, and ALC. Curcumins were safe and well-tolerated.
Clinical trial identification
NCT04208334.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.