|Year : 2021 | Volume
| Issue : 4 | Page : 427-435
Effect of medical qigong therapy on distress, fatigue, and quality of life in head and neck cancer patients undergoing intensity-modulated radiation therapy: A single arm clinical trial
Priyanka S Sagaonkar, Renu Pattanshetty
Department of Oncology Physiotherapy, KLE Academy of Higher Education and Research Institute of Physiotherapy, Belagavi, Karnataka, India
|Date of Submission||12-Sep-2020|
|Date of Acceptance||12-Oct-2020|
|Date of Web Publication||09-Apr-2021|
Dr. Priyanka S Sagaonkar
Department of Oncology Physiotherapy, KLE Academy of Higher Education and Research Institute of Physiotherapy, Nehrunagar, Belagavi - 590 010, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Cancer of Head and Neck (HNC) is the 2nd common cancer in India leading to around 8% of the global cancer mortality. Intensity-modulated radiation therapy (IMRT) is advanced method minimizing exposure of radiation to adjacent normal structures but is associated with higher fatigue indirectly elevating distress levels. Medical Qigong (MQ), a meditative mind therapy has numerous health benefits. The purpose of the current study was to investigate effect of MQ therapy on distress, fatigue, and quality of life in HNC patients undergoing IMRT. Materials and Methods: This experimental study was conducted on 16 Hospitalized HNC subjects undergoing IMRT aged 18–65 years. All the subjects performed Qigong Walk Cycle for 5 weekdays for 4 weeks from initiation of IMRT. Scores of Brief Fatigue Inventory (BFI), 6 min walk distance (6MWD), Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) were documented at the baseline and at end of 4th week and compared. Results: IBM SPSS Statistics version 23.0; Indian version of Windows was used for statistical analysis. The 16 HNC subjects majorly rural residents (62.5%) of mean age group 47.68 ± 10.25 years with tobacco chewing as prevalent habit (94%) with maximum cases recorded in stage III of the disease. The pre and post test score comparison of serum cortisol, BFI and 6MWD found high statistical significance with P = 0.001 while that of the total and all components of FACT HN was found to be significant with P ≤ 0.05. Conclusion: MQ therapy was effective in managing the levels of distress and fatigue thereby improving quality of life of all HNC subjects.
Keywords: Distress, fatigue, head and neck cancer, intensity-modulated radiation therapy, medical qigong, quality of life, serum cortisol, tobacco chewing
|How to cite this article:|
Sagaonkar PS, Pattanshetty R. Effect of medical qigong therapy on distress, fatigue, and quality of life in head and neck cancer patients undergoing intensity-modulated radiation therapy: A single arm clinical trial. World J Tradit Chin Med 2021;7:427-35
|How to cite this URL:|
Sagaonkar PS, Pattanshetty R. Effect of medical qigong therapy on distress, fatigue, and quality of life in head and neck cancer patients undergoing intensity-modulated radiation therapy: A single arm clinical trial. World J Tradit Chin Med [serial online] 2021 [cited 2022 May 18];7:427-35. Available from: https://www.wjtcm.net/text.asp?2021/7/4/427/328759
| Introduction|| |
Worldwide approximately 22 million individuals suffer from cancer with about 10 million new cases being diagnosed annually. Cancer of Head and Neck (HNC) stands 6th globally. 0.47 million cases of 0.9 million global HNC cases are from Indian territory. In the Indian population, HNC rank second among all cancers as per the National Institute of Cancer Prevention and Research leading to more than 8% of the global mortality., In males, it is the commonest cancer while in females it is the third most common cancer and accounts for 25% of the freshly found cancer cases in India with the male to female ratio of 7:1., In the Indian scenario, the age group of 40–69 years majorly suffers from HNC., The main risk factors of HNCs for the Indian population include tobacco consumption in either smoke or smokeless form, alcohol consumption, and human papilloma virus.
Intensity-modulated radiotherapy (IMRT) is a recent advancement in the world of radiation therapy which conforms to the irregularly shaped tumor target and spares the nearby normal tissue advocating more effective biological dose, improved therapeutic ratio, and no report of excessive late toxicity. Literature suggests a wide use of IMRT in treating HNCs.,
Medical Qigong (MQ) is an ancient Chinese mind-body intervention, aims for rejuvenation and healing. It is also referred to as meditative-movement therapy and incorporates practice of simple co-ordinated gentle repeated movement patterns exercising and relaxation through meditation and breathing performed in synchrony to harmonize the body, mind, and spirit offering many therapeutic benefits.,,,,,
Cancer patients undergoing radiation therapy often report distress and fatigue. Research has shown that HNC patients treated with IMRT experience higher fatigue which might increase their stress physiologically as well as psychologically. Hence, this study was undertaken with the aim to investigate the effectiveness of Qigong therapy on distress, fatigue and quality of life in HNC patients undergoing IMRT.
| Materials and Methods|| |
The present single arm clinical trial was conducted in a tertiary care hospital for the head and neck cancer subjects undergoing intensity-modulated radiation therapy. Ethical clearance from the Institutional Ethical Review Committee and the Clinical Trial Registry of India (CTRI/2019/11/022058). A written consent from the subjects in their vernacular language was acquired prior to commencement of the present study. Screening as per the inclusion and exclusion criteria before enrolment in the study was done. Hospitalized subjects who were ambulatory, within the age group of 18–65 years, with a confirmed diagnosis of head and neck malignancy by the oncologist, scheduled to receive IMRT, capable of verbal communication and willing to participate were included in the study. Subjects reporting of regular Tai chi or Qigong practice in the past year, psychiatric illness as diagnosed by the psychiatrist or any medical contraindication for exercises were excluded from the study [Figure 1].
Subjects were briefed about the nature of the study and the assessment. The assessment for distress (serum cortisol levels), fatigue levels (Brief Fatigue Inventory [BFI]), and all components of Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) for quality of life, 6 MWD for functional capacity was documented prior to the commencement and at the end of 4th week of the study. The blood sample for testing serum cortisol levels was taken by the well-trained nursing staff in the presence of the therapist at the start and end of the intervention at the same time of the day for both pre and posttests. A 40 min MQ therapy was administered for 5 weekdays for a period of 4 weeks while the subject simultaneously underwent IMRT. The 40 min of MQ therapy included 10 min of Qigong Deep Breathing Exercise [Figure 2] as warm up followed by 20 min of Qigong Walk Cycle [Figure 3]a and [Figure 3]b co-ordinated with breathing and again 10 min of Qigong Deep Breathing Exercise in the end of therapy for cool down phase.
|Figure 2: Subject performing Qigong Relaxation Technique (Breathing maneuver)|
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|Figure 3: Subjects performing Qigong Walk cycle. In two photos named a and b respectively|
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Brief fatigue inventory: [Annexure 1]
The BFI is used to assess the impact of cancer-related fatigue and its severity. It is a 9-item questionnaire that can be documented through self-report or interview with researcher helping rate level of their fatigue at current moment, its interference with their lives during the past 24 h. Lower scores represent less fatigue. Cronbach's alpha value for reliability is in the range of 0.82–0.97.
Six min walk distance
The 6MWT is an auto-paced test which assess level of functional capacity. Practically, it is an easy test requiring a 30 m hall way. This test evaluates the overall and combined responses of all systems involved while exercising.
Functional assessment of cancer therapy-head and neck quality of life scale: [Annexure 2]
FACT-HN is a scale which is currently a part of FACIT measurement system devised by Dr. David Cella used as an outcome measure of HNC patients' life's quality. It consists of 5 domains. The initial four domains of well-being consists of physical, social, emotional, and functional aspects which are common in all FACT scales. The 5th domain consists of additional concerns specific additional concerns pertaining to HNC. The patients have to mark their symptoms of the past 1 week on a scale of 0–4. Higher the score, higher is the severity of symptoms.
| Results|| |
IBM SPSS Statistics version 23.0; Indian version of Windows was used to analyze statistics of the present study. Various statistical measures such as mean, standard deviation were used to assess demographic data of all subjects participated in the study. Normality of all parameters was determined using Kolmogorov–Smirnov Test. Nominal data which included the demographic data, i.e., age, gender, area of residence, type of cancer, stage of cancer, duration of IMRT, habits were analyzed for simple frequency and percentage. All the outcome variables were normally distributed hence parametric test, i.e., “Paired t-test” was used to contrast pre and post scores of the outcome variables such as serum cortisol, 6 min walk distance (6MWD), BFI and FACT-HN Quality of life questionnaire of all the subjects with head and neck cancer. With study power of 95%, P ≤ 0.05 was considered statistically significant.
The present study included 16 subjects who received Qigong Therapy intervention along the course of IMRT for 4 weeks initiated from the day 1 of IMRT. The pre and post intervention outcomes included serum cortisol, 6MWD, BFI, and FACT-HN Quality of Life Questionnaire.
The total number of HNC subjects scheduled to receive IMRT included in the study were 16 with male dominance (100%). All the subjects were married in the mean age group of 47.68 ± 10.25 years of which 62.5% were rural residents. Tobacco chewing itself was the most prevalent common habit observed within the subjects n = 15 (94%), singly n = 11 (69%) or in combination with the other habits such as smoking and alcohol consumption n = 04 (25%). Among the cancer type within the HNC subgroup, cancer of buccal mucosa (n = 08) dominated the group with 50% followed by 31.25% tongue cancer (n = 05), 12.5% cancers of retromolar trigone (n = 02) and 6.25% cancer lip (n = 01), respectively. As per the American Joint Cancer Committee (AJCC) staging criteria, the highest number of the cancer cases in this study recorded were in Stage III (50%) [Table 1]. The comparison of the pre and post values of serum cortisol, 6 MWD, BFI of all subjects (n = 16) in the study demonstrated statistical significance (P = 0.001) which justifies clinical improvement in the level of stress, functional capacity, and fatigue [Table 2]. In terms of quality of life using the individual components of FACT-HN scale and also the Total Score of FACT HN, demonstrates high statistical significance of each of these components with P ≤ 0.05 for each which can be correlated clinically with the improvement in the various aspects of quality of life as reported by the study subjects [Table 3].
|Table 1: Demographic data of all head and neck cancer subjects (n=16) in the study|
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|Table 2: Comparison of pre- and post-values of serum cortisol, 6 min walk distance, brief fatigue inventory of all subjects in the study|
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|Table 3: Comparison of pre- and post-values of functional assessment of cancer therapy head and neck quality of life questionnaire of all subjects in the study|
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| Discussion|| |
The present study aimed to investigate effectiveness of 4 weeks MQ therapy on levels of distress, fatigue, and quality of life in the hospitalized HNC undergoing IMRT for of 5–6 weeks. The derivations of the current study affirm for effectiveness of the 4 week “MQ Walk Cycles” intervention for reducing the levels of stress and fatigue and simultaneously enhancing the Quality of Life among the hospitalized HNC subjects undergoing IMRT for 5–6 weeks. Our intervention which was a mind body intervention helped restore and rejuvenate the body's energy favoring the alternative hypothesis of this study.
In the present study, the subject's mean age group was in the range fourth decade which is in accordance with a few studies reporting higher risk and frequency of age between second to fourth decade, the risk proportionately increasing with the age.,,,
HNC has been found to be dominated among the males as per our study results. This predominance and gender association of tobacco and alcohol consumption in men is supported by many literature evidences., A study done in Karnataka state of India found the commonness with respect to the use of smokeless tobacco among males (98.79%) as compared to females (9.37%). Furthermore, it was seen that the habit of tobacco consumption was prevalent among the primary school teachers and the undergraduate medical students of Belagavi district of Karnataka with all of the consumers among them being males.,
Amongst all the HNC, oral cavity followed by oropharynx are the most likely affected sites. This observation runs in parallel to the highest number of cancer types identified in our study being Cancer of Buccal Mucosa (50%) of all cases followed by cancers of tongue, retromolar trigone, and the lip. In a review conducted by A Mishra et al. of Ca oral cavity cases from Southern India reported highest prevalence of buccal mucosal cancer (49.9%) surmounting the cases of Ca tongue (23.97%) which is again similar finding to our study.
A review found that about 80% of Oral cavity cancers in India report in the late stages mostly stage III onwards. This is relatable to the 50% cancer buccal mucosa subjects in our study of which 75% were late presentations (Stage III).
The smokeless form of tobacco consumption is established to be generally used among the tobacco consumers followed by smoking and alcohol consumption., The combined effect of tobacco and alcohol consumption is proven to have more hazardous effect on health., This observation is similar to our study wherein 94% subjects had habit of tobacco chewing alone, and 25% consumed alcohol in combination with tobacco use.
Subjects from the current study majorly belonged to the rural area of residence (62%). Their habits can be attributable to their lack of awareness and occupational ease as a study of access also owing to the fact that the Belgaum district of Karnataka is known to be one of the highest tobacco producers for trade purpose and also a consumer in high proportion in our country.
Of all the HNCs, the SCC is the most dominant tissue pathological variant (90%) which is also rightly the carcinoma variant of all subjects in our study.
IMRT has its wide application for the head and neck subsites such as cancers of oral cavity, oropharynx, nasopharynx, and paranasal sinuses. It is most commonly used for routine management nowadays as it helps reduce the treatment morbidity. However, it is hypothesized that it has less benefits in early cases (stage I of disease) or advanced malignancies with extensive metastasis like stage IV b warranting its use in our study subjects.,
In patients undergoing radiation therapy, studies warrant radiation induced fatigue as an early as well as a chronic side effect in 80% subjects during the radiation therapy phase which is in consistent with the documented data of our study wherein majority of subjects reported fatigue in the early phase of radiation therapy.
As a part of complementary and alternative medicine, Qigong therapy, a mindfulness-based rehabilitation technique is justifying its emerging role in the field of oncology rehabilitation. Review from 22 studies demonstrated a positive tenor in the physical and psychological symptoms of cancer individuals receiving Qigong treatment which is in common with findings of our study indicated by an improved scores of physical well-being (FACT HN PWB; P ≤ 0.001) and social well-being (FACT HN SWB; P ≤ 0.001) components of FACT HN questionnaire postintervention as compared with the baseline scores. A similar meta-analysis was performed to assess the effectiveness of Qigong/Tai chi on the health-related outcomes such as body composition, functional capacity, fatigue, inflammation, quality of life, and survival rate among heterogeneous cancer patients showed optimistic results in view of the two therapies. A study done by Chen et al. to evaluate effectiveness of Qigong intervention for assessing the fatigue levels in breast cancer individuals receiving radiation therapy using BFI showed a decline in fatigue levels (P ≤ 0.01) and higher life's quality (P ≤ 0.05) assessed using EORTC QLQ-30. This observation is similar to the results of present study for head and neck cancer subjects receiving IMRT, the decline in fatigue levels (P ≤ 0.001) assessed using the BFI and QoL (P ≤ 0.001) using the FACT HN questionnaire thus proving the strength of MQ intervention in cancer individuals.
The present study concluded that MQ Walk Cycle therapy was effective in managing the levels of distress and fatigue thereby improving the various aspects of quality of life of HNC subjects. However, a few limitations such as lack of a control group, no long-term follow-up to assess the continuity of practice and longevity of the results obtained with the intervention need to be considered and also, larger scale trials are warranted.
To the best of our knowledge, this study is first of its kind to evaluate for the effectiveness of “MQ Walk Cycle” intervention in HNC population and also in the subjects undergoing IMRT. It was found that MQ was an easy and feasible to exercise mindfulness-based technique in achieving symptomatic relief with a good adherence rate of subjects participating in the study thus providing insights into the use of MQ in cancer rehabilitation.
We are grateful to the Medical Director, Dr. M. V. Jali, KLES Dr. Prabhakar Kore Hospital for granting permission to carry out this study. We thank Dr. Imtiaz Ali, Radiation Oncologist (KLES Belgaum Cancer Hospital) for referring patients for the study. We thank Mr. Basant for helping us with the laboratory investigations. We are grateful to statistician Mr. Prasad Daddikar for helping us with the statistical analysis of this study. Authors are thankful to all the subjects for participating in the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]