Towards multimodal therapy in cancer fatigue: a pilot phase 2 study, prospective, randomized and double blind

Originally published in El Dolor journal 2013; 60; 26-32.

Authors

  • Guido Schiappacasse Médico Oncólogo, Centro Médico Integral (CEMIN), Avenida Progreso 279, Villa Alemana; Chile.
  • Patricio González Químico Farmacéutico, Laboratorio de Investigación en Ciencias Biológicas, Universidad de Valparaíso, Valparaíso, Chile.

DOI:

https://doi.org/10.47924/neurotarget2015215

Keywords:

Fatigue oncology, dexamethasone in cancer fatigue, multimodal therapy in cancer fatigue

Abstract

The Cancer Fatigue is one of the most common and disabling symptoms in these patients both during treatment and in advanced stages of their disease; and significantly affect the physical , emotional and cognitive dimension of the patient. And yet it is the symptom less studied by modern oncology.
Currently we do not have a standard treatment. The best available evidence shows benefit in small study of dexamethasone versus placebo in cancer fatigue in patients with advanced disease; there is also evidence of positive results by non-pharmacological strategies such as aerobic exercise programs and stress management techniques.
This study is aimed to investigate the efficacy in cancer fatigue in advanced disease of a multimodal treatment (based on non-pharmacological strategies more use of dexamethasone) versus using dexamethasone treatment alone (unimodal therapy).To do this in prospective, double-blind study 80 patients 1:1 between 20 and 80 years old with advanced malignancies were randomized to arm A multimodal treatment (pharmacological and non¬pharmacological therapy) versus unimodal therapy or arm B (single drug therapy). At study entry patients were allowed to fatigue 4 or more out of 10 using Brief Fatigue Inventory instrument, which is a form of visual analog scale (EVA) applied to cancer fatigue; and at least 2 other related symptoms (depression, anxiety and / orinsomnia), with normal cognitive function , without a super imposed infections, without brain cancer, with normal thyroid function and increased hemoglobin 9 g / dl (remember that thyroid dysfunction oranemia favors the sensation of fatigue and not excluded these factors would not draw valid conclusions). One month after treatment was reassessed by EVA fatigue (primary end point). Also were evaluated as ends side points per month of symptoms treatment of anxiety and/ or depression by HADS, sleep quality by instrument PSQI, global patient satisfaction with the treatment received by Likert scale and quality of life through instrument QLQc30 version 3.0 scale. Alpha level of significance was set at 0.05 and Chi2 statistic was used. Multimodality therapy showed an improvement of fatigue (EVA less than 4 month of treatment) relative to unimodal therapy 62.5% to 87.5% with p less than 0.01. In addition, there was a benefit in the symptoms of anxiety and depression, sleep quality, patient satisfaction with treatment received; and quality of life in a statistically significant manner. The alternative hypothesis concluding the benefit of a comprehensive treatment plan (pharmacological and non-pharmacological) on a purely pharmacological treatment plan (dexamethasone) is accepted. However, this is a pilot phase 2 study given small sampling, which reduces the statistical power in the validity of the conclusions reached; therefore, to definitively confirm the alternative hypothesis, we propose to global research groups to further research in this important topic and develop research phase 3 larger sample size.

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Published

2015-12-01

How to Cite

1.
Schiappacasse G, González P. Towards multimodal therapy in cancer fatigue: a pilot phase 2 study, prospective, randomized and double blind: Originally published in El Dolor journal 2013; 60; 26-32. NeuroTarget [Internet]. 2015 Dec. 1 [cited 2025 Oct. 16];9(4):52-8. Available from: https://neurotarget.com/index.php/nt/article/view/215

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Special Papers