Medical Oncology Unit, Centre Georges-François Leclerc, Dijon, France.
Methodology and Biostatistics Unit, Centre Georges-François Leclerc, Dijon, France.
Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:49-55. doi: 10.1016/j.ejogrb.2019.08.003. Epub 2019 Aug 12.
Breast cancer patients often benefit from adjuvant chemotherapy, a protocol whose effectiveness is accompanied by disabling adverse effects. The aim of this controlled clinical study was to determine the impact of visceral osteopathy on the incidence of nausea/vomiting, constipation and overall quality of life (QoL) in women operated for breast cancer and undergoing adjuvant chemotherapy in Centre Georges François Leclerc, CGFL.
Ninety-four women operated for a breast cancer stage 1-3, in complete resection and to whom a 3 FEC 100 chemotherapy was prescribed, were randomly allocated to experimental or placebo group. Experimental group underwent a visceral osteopathic technique and placebo group was subjected to a superficial manipulation after each chemotherapy cycle. Rate of grade ≥1 nausea/vomiting or constipation, on the first 3 cycles of FEC 100, were reported. QoL was evaluated using the EORTC QLQ-C30 questionnaire.
Rate of nausea/vomiting episodes of grade ≥1 was high in both experimental and placebo group. Constipation episodes of grade ≥1 were also frequent. No significant differences were found between the two groups concerning the rate of nausea/vomiting (p = 0.569) or constipation (p = 0.204) according to clinician reported side-effects but patient reported impact of constipation and diarrhoea on quality of life was significantly lower in experimental group (p = 0.036 and p = 0.038, respectively).
Osteopathy does not reduce the incidence of nausea/vomiting in women operated for breast cancer and undergoing adjuvant chemotherapy. In contrast, patient reported digestive quality of life was significantly ameliorated by osteopathy. Clinicaltrials.gov Identifier: NCT02840890.
乳腺癌患者通常受益于辅助化疗,这种方案的有效性伴随着使人丧失能力的不良反应。本对照临床研究的目的是确定内脏 osteopathy 在接受辅助化疗的乳腺癌术后女性中的恶心/呕吐、便秘和总体生活质量(QoL)中的影响。
94 名接受乳腺癌 1-3 期手术、完全切除且接受 3 FEC 100 化疗的女性被随机分配到实验组或安慰剂组。实验组接受内脏 osteopathy 技术,安慰剂组在每个化疗周期后接受浅表操作。报告了 FEC 100 的前 3 个周期中≥1 级恶心/呕吐或便秘的发生率。使用 EORTC QLQ-C30 问卷评估 QoL。
实验组和安慰剂组的≥1 级恶心/呕吐发生率均较高。≥1 级便秘发生率也很高。根据临床医生报告的副作用,两组间恶心/呕吐(p=0.569)或便秘(p=0.204)的发生率无显著差异,但实验组患者报告的便秘和腹泻对生活质量的影响明显较低(p=0.036 和 p=0.038)。
在接受辅助化疗的乳腺癌术后女性中,Osteopathy 并不能降低恶心/呕吐的发生率。相反,Osteopathy 显著改善了患者报告的消化 QoL。Clinicaltrials.gov 标识符:NCT02840890。