The FAFA Trial: A Phase 2 Randomized Clinical Trial on the Effect of a Fan Blowing Air on the Face to Relieve Dyspnea in Filipino Patients with Terminal Cancer

Introduction

Dyspnea is a very common symptom in patients with terminally ill cancer. When refractory, it can be an unpleasant sensation of breathlessness caused by a disease that persists despite optimum treatment directed at the underlying pathology.¹ Furthermore, not only does dyspnea increase the feeling of breathing difficulty, but also alters the patients’ quality of life and sometimes even leads to psychological changes such as fear, anxiety, and depression.^2,5

Unfortunately, dyspnea can be very difficult to alleviate and standard pathophysiological treatments can sometimes fail to satisfactorily relieve the patients’ suffering. In these situations, it is imperative to implement alternative but effective measures.^6,8 The effectiveness of these approaches are anchored on the multifaceted nature of dyspnea that involves not only sensory perception, but also cognition and emotion.^9,10 This strategic approach should not be treated as an idea or concept worth trying, but should be considered standard of care as recommended by several guidelines—one of which states that all clinicians managing patients with chronic dyspnea should be aware of the effectiveness of palliative approaches to symptom control and use these in their practice.¹¹

Various pharmacological and nonpharmacological therapies can be aimed at modulating the perception of breathlessness and the person’s response to it.^11,12 A variety of evidence-based nonpharmacological treatment options are available.^13,16 One of the strategies endorsed by the American Thoracic Society is the use of a handheld fan.¹⁷ Although the exact mechanisms responsible for the positive effect of a fan on dyspnea remains to be determined, some theories have been proposed and the most famous hypothesis states that stimulation of trigeminal nerve facial receptors “fools” the brain into believing that ventilator flow is higher than it really is, and in the process decreases the feeling of breathlessness or dyspnea. This effect is believed to be mediated by stimulation of cold-sensitive TRPM8—transient receptor potential cation channel subfamily M member 8—channels present on neurons of the trigeminal nerve and vagal afferents.^18,20

According to a Cochrane systematic review, the effects of fan use in the management of dyspnea in patients with terminal illness are still not conclusive and subject to ongoing debates and studies.²¹ This study is designed to fill in the gap of fan therapy in Filipino patients with advanced cancer, as most previous studies were targeted on the Western population.^22,31

Alleviating dyspnea in terminally ill cancer patients is a major concern, as one of the goals of palliative care is to provide comfort to the patient. Given the low cost, practical convenience, and immediate response of this approach if proven effective with no adverse effects, a clinical trial evaluating the effectiveness of fan therapy to terminally ill Filipino cancer patients will be of great value.

Objective

The objective of this study is to identify the effect of fan therapy on dyspnea in Filipino patients with terminally ill cancer. Specifically, this study aimed to:

• Identify the clinico-demographic profile of terminally ill Filipino cancer patients presenting with dyspnea who were included in this study.

• Evaluate the effect of fan therapy on dyspnea in Filipino patients with terminally ill cancer in terms of subjective improvement.

• Determine the effect of fan therapy on these patients’ respiratory rate (RR) and pulse oxygen saturation (SpO₂).

Materials and Methods

Interventions and Procedures

Participants who met the inclusion and exclusion criteria were divided into experimental and control group by block randomization. Treatment was composed of two phases with a washout period and crossover in between. Fan on face (FAFA) therapy involved directing a fan (ASAHI Fan Model PF-630) to blow air for 5 minutes across the region innervated by the second/third trigeminal nerve branches. The fan was directed toward one side of the face. The rationale for using 5 minutes of directed airflow was based on previous studies that achieved symptom palliation with this duration.^30,32 Like previous studies, the distance, location, side of face, strength, and swing of the fan was determined as per the patient’s preference.^30,31 A standing fan placed on the floor was initially turned on at the lowest speed and was gradually adjusted to increase the speed and strength of the fan breeze. In the control arm, airflow was directed unto the legs with the patient’s skin exposed for 5 minutes using the same model of the fan as that used in the intervention arm. We adopted the fan-to-legs method as the control treatment based on previous studies^32,34 Treatment crossover was performed after a washout time of 1 hour.^35,36 Methodology and data collection details are summarized in Fig. 1.

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Fig. 1 The FAFA (Fan on Face) trial study design.

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Results

Discussion

A great majority of patients with locally advanced or metastatic cancer experience dyspnea, especially during the terminal phase or when nearing the end of life. Dyspnea in these patients does not only cause physical and psychological distress to the patient, but also to the families and friends.^6,7,38,40 Thus, relieving dyspnea should be one of the clinicians’ goal as supportive and palliative care is provided.

The concept of “Total Dyspnea” states that physical, social, psychological, and spiritual factors are shown to influence our patients’ experience of dyspnea. This makes us conclude that there are numerous interventions that could be done to alleviate this distressing symptom.⁴¹ These interventions should not only be confined to relieving the structural or physiologic pathology causing the symptom, but also address the subjective experience of dyspnea. This is especially true among the terminally ill from whom invasive and aggressive interventions are, in many instances, opted out.

Although a few studies have shown that FAFA therapy is effective in decreasing dyspnea, the mechanism responsible is still poorly understood. Various theories have been proposed and the most famous hypothesis states that stimulation of the trigeminal nerve facial receptors “fools” the brain into believing that ventilator flow is higher than it really is, and in the process decreases the feeling of breathlessness. This effect is believed to be mediated by stimulation of cold-sensitive TRPM8 channels present on neurons of the trigeminal nerve and vagal afferents.^18,20 This theory is supported by a recent neuroimaging study that showed facial airflow may modify sensory perception of breathlessness in the central nervous system.⁴²

The most recent study that explored the benefits of a handheld fan on chronically dyspneic patients showed that 72% of the patients perceived some benefit.²⁵ Of the 133 patients included in this study, 21 of them had malignant conditions.

Our study focuses on the effect of FAFA therapy specifically for terminally ill Filipino cancer patients with locally advanced and metastatic cancer. The results showed a statistically significant difference between the improvement in the patients’ MBS, RR, and SpO₂ between the placebo and experimental group as shown in Table 3 (p < 0.0001). The MBS decreased by a mean score of 3 (SD: 0.92) showing similar rates of improvement in a Chinese trial.³⁷ Furthermore, the minimum clinically important difference in the MBS has been considered as 1 unit,³⁸ which was clearly achieved in this study.

However, unlike the Chinese trial, this study also showed improvements in RR with a mean decrease of 2 breaths per minute (SD: 0.94) in the experimental arm compared with placebo (p < 0.0001). Although the study results show a numerically significant improvement in SpO₂ (mean increase of 0.67%, SD: 0.75, p < 0.0001), the authors are cautiously hesitant to conclude that it has any value in terms of clinical significance.

Dyspnea often induces physical and psychological distress thereby promoting anxiety and depression. Also, one of the challenging aspects of dyspneic patients is that most of them present with intermittent dyspnea. This concept increases the importance of FAFA therapy, as its immediate availability could result in the rapid improvement of dyspnea with no known adverse effects.⁴¹

Conclusion

This is the first study to provide additional evidence to support the use of FAFA therapy (blowing air from an electric fan directly on the face) specifically for Filipino patients with terminal cancer in addition to the prescribed standard of care. it was shown to significantly alleviate their level of dyspnea as evidenced by a subjective decrease in their MBS score and slight objective decrease in their RR. Thus, FAFA therapy should be considered as an adjunct to standard of care for these patients.

Recommendations

Results of this study can provide future researchers with the first evidence that shows the effectiveness of FAFA therapy in alleviating dyspnea in Filipino patients with terminal cancer. In line with this, a similar but larger-scale and multi-institutional study may be done to increase the generalizability of the findings.

A study on the factors affecting the effectiveness of FAFA therapy in these subset of patients may be explored—factors that encompass but are not limited to optimal duration and method of delivering the intervention (e.g., stand fan vs. handheld fan), and patient factors that are most likely to benefit from FAFA therapy.

FAFA therapy as a safe and accessible adjunct to standard of care should be included in the provision of supportive and palliative care for these patients.