Visceral osteopathic manipulative treatment reduces patient reported digestive toxicities induced by adjuvant chemotherapy in breast cancer

Participants

• Number: 94 women
• Criteria of inclusion: women of age > 18 years, operated for breast cancer stage 1-3, in complete resection, undergoing three cycles of FEC 100 chemotherapy (5-fluorouracil, epirubicin, cyclophosphamide intravenously)
• Criteria of exclusion: metastatic breast cancer, surgery with incomplete resection, diagnosis of digestive disorders/diseases, inability to tolerate antiemetic treatment
• Study groups: two groups obtained by randomization
  • Group 1: visceral OMT, 54 women (mean age 57.5 years)
  • 5 women abandoned the study while 13 did not meet at least one of the inclusion/exclusion criteria
  • Group 2: superficial manipulation, 40 women (mean age 5.1 years)
  • 3 women abandoned the study while 12 did not meet at least one of the inclusion/exclusion criteria

Interventions and evaluations

• Evaluation of nausea/vomiting and constipation according to CTCAE for 9 weeks (the duration of the 3 courses of chemotherapy)
• Evaluation of quality of life using EORTC QLQ-C30 at the time of the inclusion in the study and after each course of chemotherapy
  • scores regarding overall health, nausea/vomiting, intestinal symptoms /constipation and diarrhea
• Evaluation of the drugs taken
• All women received a prophylactic antiemetic treatment
  • aprepitant, intravenous ondansetron, intravenous methylprednisolone, metoclopramide pills, alprazolam pills
• 3 15-minute sessions of OMT or superficial manipulation, 1 after each cycle of chemotherapy
• Visceral OMT: deep thoracic fascia and diaphragm relaxation through thoracic compressions
• Superficial manipulation: superficial massage without affecting the deep fascia or the abdominal structures (the compressions have been performed with less force to avoid stimulating the diaphragm or the intercostal muscles)
• OMT performed by one certified osteopath

Results

• Primary outcomes: the OMT group reported a nausea/vomiting rate of at least grade 1 of 80.4%, while the control group reported a rate of 87.2%, but this difference was not statistically significant. The result was the same excluding the women who did not meet the inclusion/exclusion criteria.
• Secondary outcomes: the OMT group reported a rate of nausea/vomiting episodes of at least grade 1 of 47.1%, while the control group reported a rate of 61.5%, however, this difference was not statistically significant. The result was the same including the women who did not meet the criteria of inclusion/exclusion. With regard to quality of life, the overall health score remained constant throughout the study and similar in both groups. The nausea and vomiting score improved as the study progressed in both groups in a statistically significant manner. The score for constipation and diarrhea was higher in the control group than in the OMT in a statistically significant way, showing a better OMT action.
• Further analyses: there was no statistically significant difference in the use of medications to treat constipation or diarrhea between the two groups, although the control group showed a tendency to use a greater number of anti-constipation drugs.

Discussion

The nausea/vomiting rate reported in the study was particularly high despite the prophylactic antiemetic treatment (in any case the majority was of grade 1, ie, aversion to food), and also visceral OMT did not show an important reduction of these episodes. Similarly, visceral OMT does not appear to have improved quality of life in relation to nausea/vomiting.

With regard to constipation, however, although OMT did not lead to a significant reduction in episodes, it has improved the quality of life associated with it compared to the superficial manipulation (in fact this group made more use of laxative drugs).

The current result contrasts with other past results on the usefulness of massage and OMT in reducing nausea during chemotherapy: however, a number of differences (lack of description of the chemotherapy used, different types of tumors, different treatments) prevent a proper comparison of the studies.
Larger studies are needed, with better randomization, involving more osteopaths and evaluating OMT in a broader way.