Physiotherapy intervention on changes in post-chemotherapy sensibility with taxanes

doi:10.21203/rs.3.rs-1859594/v1

OBJECTIVE: Evaluate the presence of changes in post-chemotherapy sensibility with Taxane and the efficiency of a physiotherapy intervention that aims at the improvement of this condition.

METHODS: We conducted an uncontrolled, longitudinal quantitative and prospective study on 23 patients. Four were not included in the study for not showing changes in sensibility or having a skin condition that rendered the evaluation impossible. The patients responded to the McGill and FACT G-Taxane questionnaires after the sensibility evaluation with a Semmes-Weinstein esthesiometer, an intervention session using a Peridell® therapeutic massager and a subsequent sensibility revaluation.

RESULTS: Two regions with the best responses to the intervention were the dermatomes L5 and S1, with initial means of 5.33 and 5.53 and final means of 5.64 and 5.78, respectively (p = 0.012 e 0.020). The general analysis for both superior and inferior limbs showed an increase in the means, with an initial mean of 5.69 and a final mean of 5.81 (p = <0.001). There was a negative correlation between FACT G-Taxane and the McGill Questionnaire (-0.738 e p = <0.001).

CONCLUSION: Vibratory stimulus of Peridell® therapeutic massager showed a significant improvement of changes in sensibility on the region of the dermatomes L5 and S1, especially on milder changes. The correlation between FACT G-Taxane and the McGill questionnaire suggests that the more pain the patient feels, there is less life quality and there are more symptoms of toxicity.

Breast Cancer

Chemotherapy

Neuropathy

Physiotherapy

Rehabilitation

Breast Cancer is the most common malignant neoplasia in the female population all over the world. Historically, it is more common in developed countries, but the rates also increased in developing countries [1, 2]. Represents about 20% of the total of cancer cases and 15% of the deaths resultant of this condition. Data from the National Cancer Institute (INCA) estimate 66.280 new cases of breast cancer for each year of the 2020–2022 triennial [3, 4].

The treatment for breast cancer entails the possibility of a local approach, as surgery and radiotherapy, as well as a systemic approach, such as chemotherapy, hormone therapy and immunotherapy. Usually, there is a combination of therapies that aim at the best result and prognosis. The surgical procedure can be conservative (setorectomy, tumorectomy and quadrantectomy) or non-conservative (mastectomy). Whenever possible, the conservative surgical procedure is the most utilized approach to ensure the best esthetic results. However, the mastectomycan also be chosen after an analysis of the histological type of the tumor and its size — usually, bigger than 3 centimeters [5, 6].

The chemotherapy consists of the handling and administration of one or more drugs in order to reduce the quantity of neoplastic cells present in the affected tissue. Most of these substances act in a non-specific way, resulting, besides the death of abnormal cells, injuries on normal cells [7]. Taxanes are chemotherapeutic used on breast cancer treatment. In Brazil, there are two types: Paclitaxel and Docetaxel. According to Donatti [8], the most common side effects of these drugs are neutropenia and mucositis. However, the chemotherapy-induced peripheral neuropathies (CIPN) is also an effect of the toxicity of these drugs and can cause pain, paresthesia (especially on the hands and feet), distal muscular dystrophy, among other effects[9].

The term “paresthesia” is defined as subjective cutaneous sensations (cold, warmth, tingling, numbness and pressure) felt during the absence of direct stimulation over the skin region. When the path of the sensitive nerve shows any injury, there are changes in the sensibility of the skin region of innervation[10].

Regarding the changes caused by chemotherapeutic drugs, the symptoms tend to be progressive and dependent on the dosage and the time of treatment. Besides that, the presenting symptoms is usually symmetrical and distal, in “boots and gloves” (e.g. hands and feet) [9, 11]. These symptoms — pain and paresthesia — have an impact on the life quality and the treatment process. If symptoms are highly debilitating, a change on the dosage of antineoplasics is necessary. In some cases, an interruption of the therapy is needed [9]. There is a need of a therapeutical development and analysis that help on minimizing the effects of this condition, enabling the continuity of the chemotherapy treatment and more.

Currently, vibrators are used for “playful” purposes and sexual satisfaction. Their creation dates back to the 19th century for medicinal purposes. Vibrators were used to massage the vulvar region, when women were “hysterical”, feeling “anxiety, lack of sleep, irritability, nervousness, erotic fantasies, feelings of heaviness in the abdomen, edema in the lower pelvic region and vaginal lubrication” [12, 13].

There are studies about the use of a vibrator for therapeutic purposes in treating sexual dysfunction with good results [12, 14]. In addition, the vibration can also be used to stimulate the sensibility on both hands and feet, enabling a new function for this material, especially for CPIN patients.

Rationale

The adoption of certain chemotherapeutics has been useful in increasing the global life expectancy of women with breast cancer. However, the complications arising from the treatment can negatively affect the life quality of these patients, resulting in side effects — one of them being CPIN — with symptoms difficult to control. Therefore, the search for therapeutic methods that assist in controlling and reducing the lack of sensibility and pain and, therefore, ensuring better care and life quality for these patients.

Objective

Evaluate the presence of changes in sensibility post-chemotherapy with Taxanes and the efficiency of a physiotherapy intervention that aims at the improvement of this condition.

This is an uncontrolled, longitudinal, quantitative and prospective study. It was approved by the Ethics and Research Committee (CEP) of the Universidade Federal de São Paulo (UNIFESP), by the reference number: 3.938.454. CEP/UNIFESP number: 1185/2019. All the patients signed the consent form. Clinical Trials in protocol number - NCT 03373032.

The criteria of inclusion were women diagnosed with breast cancer after conducting the chemotherapy protocol with Taxanes; the presence of changes in sensibility at the evaluation using an esthesiometer, starting with the Blue color (0.2 g).

The criteria of exclusion were patients who did not wish to participate of the study, patients with cognitive deficit, changes in sensibility before the chemotherapy or skin lesions that made the evaluation and intervention impossible.

Intervention description

The medical treatments were conducted at the Oncomastology ambulatory, during the Mastology class at the Gynecology Department and, eventually, at the Palliative Care ambulatory, during the Medical Practice class, both at UNIFESP. The patients were treated with all the interventions. The McGill questionnaire, to evaluate the pain, and the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) questionnaire, to evaluate the sensibility with an esthesiometer, were filled. In cases in which there were changes, it was performed a stimulation of proprioception with the therapeutic massager Peridell®. Then, there was a revaluation of sensibility to verify the results obtained, comparing both questionnaires.

McGill Pain Questionnaire

The McGill Pain Questionnaire (MPQ), translated to Portuguese as “Questionário de dor de McGill” and validated by Castro (1999) in his Master’s thesis, as cited by Santos et al. [15], enables the pain evaluation in a multidimensional way, presenting four descriptors (sensitive, affective, evaluative and miscellaneous) that, together, account for 78 words, used to characterize the feeling of pain. These four groups were organized in 20 subgroups according to the kind of pain. The subgroups from 1 to 10 represent sensitive responses to painful experiences (traction, warmth, sprain, among others). The descriptors of the subgroups from 11 to 15 are the responses to affection (fear, punishment, neurovegetative responses, etc.). The subgroup number 16 is evaluative (evaluation of the global experience), whereas the ones from 17 to 20 are miscellaneous.

FACT-Taxane Questionnaire

FACT–Taxane (www.facit.org) evaluates the life quality and the concerns with patients who went through chemotherapy and can show neurotoxicity or not. It is composed of 16 specific items about changes in sensibility of hands and feet. Zero is the worst score and 64 is the best score. The score for each question vary between 0 and 4 [16]. The request to use the questionnaire was made through the site www.facit.org and authorized.

Sensibility

A Semmes-Weinstein esthesiometer, (Sorri®, Bauru/SP, Brazil), evaluates and quantifies the limit of pressure on the respective dermatomes, assisting in detecting and monitoring nerve lesions. The material is composed of a set of six plastic tubes, each with a pair of monofilaments of special nylon. The width and the traction (in grams) necessary to bend the filaments range from 0.05 to 300 g. Green (0.05 g), blue (0.2 g), purple (2.0 g), red (4.0 g), orange (10.0 g) and pink (300 g) [17]⁾. For purposes of statistical calculations, a value was allocated to each color: green − 6, blue − 5, purple − 4, red − 3, orange − 2, pink − 1. Changes in sensibility were considered through the color blue.

Considering that one of the side effects of the treatment with taxanes is CPIN, also known as hands/feet syndrome, the following dermatome will be evaluated:

Superior limbs: C6, C7, C8, T1;
Inferior limbs: L5, S1 and L5 - sole of the feet.

During the evaluation and revaluation with the esthesiometer (Fig. 1), the patient was asked to keep her eyes closed and say if she felt the monofilament through the trajectory of the referred dermatome. The stimulus starts with the less thick monofilament (green). In cases in which the patient did not feel anything, the next color in the sequence of available thickness was used and so on, until the patient felt anything.

Peridell® Massager

Peridell® is a vibration device for therapeutic massage on the perineal region and, according to its manufacturer (Hot Flowers® – Indaiatuba/SP, Brazil), it can be used in the treatment of urinary and fecal incontinence, the improvement of constipation, better maintenance of pelvic organs, besides contributing to feminine and masculine sexuality. It consist of a robust and cylindrical plastic vibrator (with a power capacity of 30 Hertz to 142 Hertz), with four interchangeable tips in varying formats. Due to its better contact with the skin, the straight tip was used [18].

There was an intervention with the Peridell® throughout the dermatomes mentioned in the subsection “Sensibility”. The massager, in its full power capacity, was slowly used on each dermatome, in cephalic caudal direction. The intervention, in each dermatome, lasted an average of was five minutes.

Analysis and Statistics

The following softwares were used: SPSS V20, Minitab 16 and Excel Office 2010. For this work, a level of significance of p = 0.05 (5%) was defined, as well as a confidence interval with a statistical confidence of 95%.The normality of the quantitative variables of the main outcome was analyzed through the Kolmogorov-Smirnov (KS) Test and the distribution of assured normality. Therefore, the statistical tests used were not parametric.

22 female patients were evaluated at the Oncomastology ambulatory. Among those, 3 did not show changes in sensibility during the evaluation with an esthesiometer, so they were not included in this analysis. Besides that, one patient showed hyperemia and lesions on the sole of the feet on the day of the evaluation, making the use of the esthesiometer impossible. She was sent to a specialist and was not included in this analysis. Therefore, 18 women received intervention with the Peridell® massager.

Table 1, presents information about how the group participates. Most of them are aged between 50 and 59 ye ars (33.3%) and have completed high school (61.1%). In addition, just over half (55.5%) were diagnosed with right breast cancer. The majority (83.3%) underwent neoadjuvant chemotherapy.

Table 1

Sociodemographic characteristics
	N (18)	%
Age (38–76 years)
30–39	1	5,5
40–49	5	27,7
50–59	6	33,3
60–69	4	22,2
70–79	2	11,1
Scholarity
Primary	5	27,7
Secondary	11	61,1
College	2	11,1
Breast
Right	10	55,5
Left	7	38,8
Both	1	5,5
Chemotherapy
Neoadjuvant	15	83,3
Adjuvant	3	16,6
Caption: N - Number of calculated measures.
% - Percentage.

Table 2, data referring to the evaluations of sensibility before (initial) and after (final) the intervention, comparing the dermatomes evaluated. Statistical significance in both positions: “L5” and “S1”. The increased mean: 5.33 to 5.64 (p-value = 0.012) on L5; and 5.53 to 5.78 (p-value = 0.020) in S1.

Table 2

Comparison between (initial and final) moments of sensibility on dermatomes.
		Mean	Median	Standard deviation	N	CI	P-value
C6	Initial	5.97	6	0.17	6	0.05	0.317
	Final	6.00	6	0.00	36	—
C7	Initial	5.86	6	0.35	36	0.11	0.180
	Final	5.94	6	0.23	36	0.08
C8	Initial	5.92	6	0.28	36	0.09	0.564
	Final	5.94	6	0.23	36	0.08
T1	Initial	5.83	6	0.51	36	0.17	0.063
	Final	6.00	6	0.00	36	—
L5	Initial	5.33	5	0.72	36	0.23	0.012
	Final	5.64	6	0.59	36	0.19
S1	Initial	5.53	6	0.56	36	0.18	0.020
	Final	5.78	6	0.42	36	0.14
L5 - sole of the feet	Initial Final	5.36 5.39	5 6	0.68 0.77	36 36	0.22 0.25	0.739
Caption: N - Number of calculated measures. CI - Confidence interval. Source: Wilcoxon Test, equality between two proportions test.

Table 3, comparison between superior and inferior limbs, besides an analysis of both extremities (general). There was an increase on the statistically significance mean on the three results. On the “general” comparison, the mean increased from 5.69 to 5.81 (p-value < 0.001).

Table 3

Comparison between (initial and final) moments of sensibility on limbs.
		Mean	Median	Standard deviation	N	CI	P-value
Superior	Initial	5.90	6	0.35	144	0.06	0.01
	Final	5.97	6	0.16	144	0.03
Inferior	Initial	5.41	5.5	0.66	108	0.12	0.001
	Final	5.60	6	0.63	108	0.12
General	Initial	5.69	6	0.56	252	0.07	< 0.001
	Final	5.81	6	0.46	252	0.06
Caption: N - Number of calculated measures. CI - Confidence interval.Source: Wilcoxon Test, equality between two proportions test.

Table 4, correlation between the McGill and the FACT G-Taxane questionnaires. Based on the Spearman correlation (Corr (r)), this value can range between − 1 and 1. There is a correlation on the FACT G-Taxane score with the McGill Groups. All correlations are negative; the questionnaires present inversely proportional values, showing that the greater the quantity of McGill descriptors, the less the FACT G-Taxane score. Analyzing the “total”, there is a correlation of -0.738.

Table 4

Correlation between the FACT G-Taxane and the McGill questionnaire.
McGill	FACT
McGill	Corr (r)	P-value
Sensitive	-0.611	0.007
Affective	-0.778	< 0.001
Miscellaneous	-0,764	< 0.001
Total	-0.738	< 0.001
Caption: Corr (r) - Correlation
Source: Spearman's rank correlation test.

The purpose of this study was to analyze the sensibility on patients that went through chemotherapy with Taxane and the efficiency of the Peridell® massager. The L5 and S1 dermatomes showed the best response to the intervention, which were the skin regions with the worst means on the initial evaluation: 5.33 and 5.53, respectively. This data matches with the literature review, in which patients with CPIN symptoms showed the worst vibratory perception and the most pain on the inferior limbs when compared to the superior limbs [9, 19].

According to the literature, the incidence of CPIN is not well determined, because the rates presented in studies vary widely (from 10–100%), especially in therapies using taxanes and derived of platinum. This variation can occur because of the different techniques to evaluate and diagnose the occurrence of CPIN, besides the clinical characteristics in each case. Besides, the possibility of reducing the dosage or even suspending the treatment, due to the toxicity presented and the resulting reduction when controlling the disease, can cause concerns on patients, who tend to neglect the symptoms [9]. All the participants in this study showed signs of toxicity, but there weren’t any specific diagnosis to CPIN. This is a limiting factor and it can be analyzed in another research.

Santos et al. [20], used the Semmes-Weinstein esthesiometer to evaluate possible changes in sensibility towards the intercostobrachial nerve on women with breast cancer, submitted to axillar lymphadenectomy, in comparison to women without breast cancer that were not submitted to surgeries in the axillar region. According to the results, the alterations in sensibility had a high prevalence (81.5%) on patients with breast cancer. Therefore, the equipment is reliable to evaluation, so it does not present risks to the patients, because it is simple and safe.

In the literature review, there were no data about the specific use of therapeutic massagers in changes in sensibility related to chemotherapy. However, a study analyzing the role of physiotherapy on sexual function of women with genitopelvic pain/penetration disorder used the Peridell® massager, among other resources, in myofascial releasing on the perineal region and the musculature desensitizing on the hip region. The study showed good results. The pain reduced and the sexual function improved after 16 physiotherapy sessions twice a week [21].

In a randomized clinical trial, Streckmann et al.[19] evaluated two protocols: sensorimotor training and whole-body vibration training (on a platform). Each group, with 10 participants, exercised twice a week during six weeks. The group of sensimotor training showed the best results when evaluating the tendinous reflexes and the subjective report about the symptoms while the group of vibration training was superior, in relation to the pain episodes. The authors concluded that both protocols were efficient and safe to the patients. The vibration triggers a mechanical stimulation on axon terminals and induces the release of local mediators that influence the receptors and terminals at the nerve periphery.

Besides it being a different technique than the one we performed, it is possible to conclude that the vibration with the Peridell® massager causes the same effect as a whole-body vibration, but to a lesser extent due to its specific location. Equally, it stimulates the sensitive receptors. Another important factor of this study is that patients only received one treatment and showed an immediate improvement during the revaluation using an esthesiometer.

The chemotherapy is among the most common neuropathic pains and its clinical, behavioral and social presentation can differ between patients, even if the root cause is the same. This behavior involves psychological, familiar and social factors, that can contribute positively or negatively. Therefore, it is important adopting a biopsychosocial model in the treatment, that aims to control not only the symptom, but especially the patient education and the function restoration [22]. In our study, there was a negative correlation between the scores of the FACT G-Taxane and the McGill questionnaires, showing that the pain can reduce the perception of life quality of the patients. The more pain the patient feels, the lesser is her life quality and there is more toxicity related to her chemotherapy.This data befits the findings on the literature, in which many studies mention the negative impact of CPIN symptoms, especially the pain, significantly reducing the life quality of these patients [9, 11, 23].

Through the data gathered, we can concluded that the Peridell® massager was efficient as a proprioceptive stimulus on forearm, hands, legs and feet. We were not able to change the power capacity in Hertz of the device, so it was used in its full capacity (142 Hertz). There was a negative correlation between the highest scores on the McGill questionnaire with the lowest scores on the FACT G-Taxane questionnaire, suggesting the link between pain and life quality.

Vibratory stimulus of the Peridell® massager showed a significant result in changing the sensibility of L5 and S1 dermatomes, especially in lighter changes. The algic episodes influence the perception of life quality of the quality. New studies are necessary to evaluate the response to the stimulus with the Peridell® massager in the long term and increased focus of the pain episodes.

Ethics approval and consent to participate

This study approval was granted by the Ethics and Research Committee (CEP) of the Universidade Federal de São Paulo (UNIFESP), by the reference number: 3.938.454. CEP/UNIFESP number: 1185/2019. Clinical Trials in protocol number - NCT 03373032. All the patients signed the consent form. Patients signed informed consent regarding publishing their data.

Consent for publication

Informed consent was obtained from all individual participants included in the study. Consensus term in accordance with Resolution 466/1 of the CEP/CONEP (Research Ethics Committees/National Research Ethics Commission). All participated voluntarily and without remuneration.

Availability of data and materials

Data were analyzed using SPSS V20, Minitab 16 and Excel Office 2010 software. The materials used were the McGill pain questionnaires and FACT-Taxane, the Semmes-Weinstein esthesiometer and the Peridell device.

Funding

The authors have no financial or proprietary interests in any material discussed in this article. The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Authors' contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Maria Thais Rodrigues, Roberta Pitta Costa Luz, Carmen Sylvia Varella Alliz and Thais Andreotti Gelsi Reis. The first draft of the manuscript was written by Maria Thais Rodrigues and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Acknowledgements

Our thanks to Fabiane Dell for donating the Peridell® devices to the Oncomastology ambulatory, enabling the use of the material and the analysis of its efficiency. Our thanks to Doctor Ana Paula de Oliveira Ramos for providing a practice in the Palliative Care ambulatory to conduct the evaluations and interventions when the Oncomastology ambulatory was not available.

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No competing interests reported.

Physiotherapy intervention on changes in post-chemotherapy sensibility with taxanes

Status:

Version 1

Abstract

Figures

Introduction

Rationale

Objective

Methods

Intervention description

McGill Pain Questionnaire

FACT-Taxane Questionnaire

Sensibility

Peridell® Massager

Analysis and Statistics

Results

Discussion

Conclusions

Declarations

References

Additional Declarations

Status:

Version 1