scholarly journals Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients

2016 ◽  
Vol 11 (1) ◽  
Author(s):  
David N. Teguh ◽  
René Bol Raap ◽  
Henk Struikmans ◽  
Cees Verhoef ◽  
Linetta B. Koppert ◽  
...  
Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
M. C. T. Batenburg ◽  
H. J. G. D. van den Bongard ◽  
C. E. Kleynen ◽  
W. Maarse ◽  
A. Witkamp ◽  
...  

Abstract Background Breast cancer treatment with radiotherapy can induce late radiation toxicity, characterized by pain, fibrosis, edema, impaired arm mobility, and poor cosmetic outcome. Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for late radiation toxicity; however, high-level evidence of effectiveness is lacking. As HBOT is standard treatment and reimbursed by insurers, performing classic randomized controlled trials is difficult. The “Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity” (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design. Methods The HONEY trial will be conducted within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation (UMBRELLA). Within UMBRELLA, breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion. Patients consent to collection of clinical data and patient-reported outcomes and provide broad consent for randomization into future intervention studies. Patients who meet the HONEY in- and exclusion criteria (participation ≥ 12 months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease) will be randomized to HBOT or control group on a 2:1 ratio (n = 120). Patients in the control group will not be informed about participation in the trial. Patients in the intervention arm will undergo 30–40 HBOT treatment sessions in a high pressure chamber (2.4 atmospheres absolute) where they inhale 100% oxygen through a mask. Cohort outcome measures (i.e., physical outcomes, quality of life, fatigue, and cosmetic satisfaction) of the HBOT group will be compared to the control group at 3 months follow-up. Discussion This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design. Use of the TwiCs design is expected to address issues encountered in classic randomized controlled trials, such as contamination (i.e., HBOT in the control group) and disappointment bias, and generate information about acceptability of HBOT. Trial registration ClinicalTrials.gov. NCT04193722. Registered on 10 December 2019.


2018 ◽  
Vol 44 (7) ◽  
pp. 963-968 ◽  
Author(s):  
M. Lagendijk ◽  
L.S.E. van Egdom ◽  
C. Richel ◽  
N. van Leeuwen ◽  
C. Verhoef ◽  
...  

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 103s-103s
Author(s):  
Z.Y. Lim ◽  
N. Rajaram ◽  
C.V. Song ◽  
R. Kaur ◽  
N.A. Mohd Taib ◽  
...  

Background: Patient-reported outcome measures (PROMs) are essential for identifying how patients perceive the outcomes of their cancer treatment, and is the ultimate success of cancer care. Although a growing number of studies have focused on PROMs in high income countries (HICs), outcomes relevant to patients in developing countries are less understood. Furthermore, the lack of standardization in PROMs makes it difficult to interpret these data for research or quality monitoring. Aim: In this study, we compared the results of PROM measures between patients in Malaysia, a middle income country, and those in HICs, using standard PROMs questionnaires. We also explored the differences in perceived importance of patient reported outcomes within the multiracial Malaysian cohort. Methods: Breast cancer patients (n=1063) were recruited in hospitals serving suburban areas of Malaysia. Of these, 969 patients were eligible for analysis. The surveys were conducted through face-to-face interviews (68%) or were self-administered (30%). An outcome was considered important if it was scored between 7-9 on a 9-point Likert scale. We compared PROMs scores between Malaysian patients and data previously collected from patients in HICs using logistic regression models, adjusting for demographic and clinical characteristics. A two-step cluster analysis was conducted to explore differences in the perceived importance of PROMs between clusters of Malaysian patients. Results: Compared with 1777 patients from HICs, Malaysian patients were less likely to rate overall and recurrence free survival, as well as emotional, cognitive, social and sexual functioning as very important outcomes. Interestingly, more Malaysian women reported that pain (50% vs. 39%), breast symptoms (51% vs. 35%), and major complications (60% vs. 44%) were very important outcomes ( P < 0.001). Compared with young, married Malaysian women, the cluster of older married women (mean age of 57 vs. 52), who were less likely to have received breast reconstructive surgery (8.6% vs. 16.8%), was more likely to rate sexual functioning (32.8% vs. 25.0%, P = 0.036), body image (63.9% vs. 42.4%, P < 0.001), and satisfaction with the breast (50.7% vs. 37.0%, P = 0.011) as very important outcomes. Conclusion: The differences in breast cancer patient needs between and within populations should be considered carefully to better clinician-patient relationship, patient care and satisfaction and assess the outcomes of our cancer care. Future research is needed to find suitable targeted interventions to identify and address the diverse needs of breast cancer patients in low and middle income countries.


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