Investigating the safety and feasibility of osteopathic medicine in the pediatric oncology outpatient setting

Participants

• Number: 23 people (13 female and 10 male, mean age 12 years)
• Criteria of inclusion: children and young people (ages from 2 to 21 years), chemotherapy treatment following diagnosis of cancer disease at Nationwide Children’s Hospital, weekly outpatient visits to oncology clinics during the 2-month study period, patients scheduled to receive at least 1 dose of vincristine (chemotherapy drug) during the study.
• Criteria of exclusion: pregnant or breastfeeding girls; past malignancy or presence of conditions such as (but not limited to) inflammatory bowel disease, diabetes, chronic pain syndromes, chronic neuropathic pain, trisomy 21 and other genetic conditions; inability to answer questionnaires due to language difficulties.
• Groups of study: OMT, 23 people (13 female and 10 male, mean age 12 years)
  • 9 participants with leukemia, 7 with lymphoma, 6 with sarcoma, and 1 with neuroblastoma.

Interventions and evaluations

• Evaluation of the percentage of patients available to receive OMT in 2 out of 3 of their outpatient visits during a 10-week period.
• Evaluation of adverse events by CTCAE criteria as ordered by the National Cancer Institute.
• Nursing staff were asked to fill out a questionnaire after each visit, collecting data regarding any interruptions in workflow due to OMT.
• Assessment of pain using FACES questionnaire and bowel habits through various questions and through Bristol Stool Scale before and after each treatment.
• At each visit, data collection of the current oncology drug therapy and of the use of particular medications during the previous week for particular needs.
• 8 weekly OMT sessions during the course of a 20-minute visit.
  • If a patient was hospitalized, he or she would not receive OMT during that week in order to maintain the OMT exclusively as  outpatient therapy.
• OMT: myofascial release, muscle energy techniques, balanced ligament tension, visceral manipulation (including ventral abdominal release and inhibitory pressures directed at the celiac, superior and inferior mesenteric ganglia).
• OMT performed by only one osteopath.
• If needed, on the recommendation of the medical team, patients could receive antibiotics, transfusions, anti-emetics, fluids, electrolytes and supportive care including massage or physical therapy.

Results

Primary outcomes: of 23 participants, 2 patients took part in less than 6 visits, therefore, only the remaining 21 were analyzed for the study, all of which were willing to receive OMT at 2 of their 3 outpatient visits as they had a positive opinion about it.
Regarding adverse events, there were no serious adverse events that could be attributed to OMT. Before recruitment, chemotherapy had induced a few cases of deep vein thrombosis, leg pain, and constipation, none of which were worsened by OMT. On the other hand, 3 adverse events, namely Clostridium difficile infection, neutropenic enterocolitis, and fatigue with nausea, emerged due to oncological pathology or chemotherapy.
Some of the osteopathic visits were not carried out for various reasons: hospitalization, adverse effects from chemotherapy, transition to palliative care, the osteopath’s unavailability due to other commitments, Covid-19. Only one patient (not included in the 23 participants) did not want to continue OMT after the first visit because of “medical anxiety” (a child’s anxiety about having to see a doctor or go to the hospital).
Finally, the nursing staff did not show any kind of delay or interruption in workflow due to OMT, taking into account that the osteopathic visits lasted an average of 14.2 minutes.

Secondary outcomes: with regard to bowel habits, participants often reported no constipation after OMT, even with very hard stools according to the Bristol Stool Scale. However, it was found that personal assessment of constipation and Bristol Stool Scale score often did not coincide.
Regarding pain, the median value obtained with the FACES score was always equal to 0, both before and after OMT. Some patients reported decreased pain after OMT, while none reported increased pain after OMT.

Discussion

OMT showed no adverse effects, was well accepted by all patients analysed, and promoted improvement in pain perception and bowel evacuation. In addition, the nursing staff considered OMT to be well included in their work routine; in fact, they did not point out any delays or problems due to the osteopathic visits. Indeed, given that the osteopathic visit lasts about 14 minutes against the 80 minutes of a regular visit in an oncology clinic, the osteopathic visit can be considered easily integrated into a routine visit.

Given the preliminary results obtained, the addition of OMT could improve the overall satisfaction of pediatric cancer patients, and even their compliance with drug treatments.

Given its lack of adverse effects, OMT could also be an excellent intervention to solve problems of constipation, very common in these patients due to chemotherapy, fatigue, that prevents physical activity (which would promote bowel motility), and swallowing, which prevent proper nutrition. In fact, meta-analyses on pharmacological interventions for constipation have shown many serious adverse events: diarrhea, abdominal pain, nausea, vomiting, pain or fatigue during evacuation, bloating, flatulence, hard stools, and rectal bleeding.

The same applies to the management of pain, as opioids can bring constipation (sic!), itching, sedation, urinary retention and respiratory depression, while non-opioids can be toxic (eg, hepatotoxicity of acetaminophen) or alter blood parameters related to coagulation (non-steroidal anti-inflammatory drugs).

Particular and worthy of further investigation was the discrepancy between personal perception of constipation and the Bristol Stool Scale score, which indicates both stool consistency and expected degree of constipation.

However, all of these results need further investigation because the study examined a small sample, certainly not representative of the entire pediatric oncology setting, and the treatments followed by individual patients – treatments that could have affected the outcomes measured – were not analyzed.