Define and Conquer? IM and GYN Cancer
Define and Conquer? IM and GYN Cancer
Abstract & Commentary
By Russell H. Greenfield, MD, Editor
Synopsis: Results from this small pilot trial suggest that clinical hypnosis, massage, and energy work can all be offered to people receiving chemotherapy without interfering with conventional medical care. The findings also suggest little clinical benefit, but there are considerable study limitations, and the findings speak more to feasibility than to therapeutic utility.
Source: Judson PL, et al. A prospective, randomized trial of integrative medicine for women with ovarian cancer. Gynecol Oncol 2011;123:346-350.
In a prospective, randomized controlled pilot trial performed at the University of Minnesota, researchers sought to assess the feasibility of providing integrative medical care (IM) to women receiving treatment for gynecologic malignancy. Women were eligible to participate if they had newly diagnosed ovarian, primary peritoneal, or fallopian tube carcinoma at any stage or histology, and were scheduled to receive at least six cycles of chemotherapy. Those subjects randomized to the control group received standard treatment for nausea and vomiting, and bone marrow support. While not prohibited, they were also encouraged not to seek complementary and alternative medical (CAM) therapies. Women randomized to the IM group received clinical hypnosis, massage therapy, and healing touch at the time of administration of chemotherapy. Participation in support groups was freely permitted.
Clinical hypnosis was performed three times in the presence of a hypnotherapist (chemotherapy cycles 1, 2, and 4). These sessions were recorded and patients were given headsets to listen to them whenever they desired and at chemotherapy cycles 3, 5, and 6. Prior to the first hypnosis session, subjects were given a pamphlet describing the therapy, and subjects were asked to identify their major concerns and ways they thought such concerns might be quelled. The content of the hypnosis sessions were then semi-structured to the individual's needs. The initial session lasted 60 minutes, all others were 30 minutes in duration, and afterwards the subject's experience with hypnosis was evaluated.
Therapeutic massage was administered with each cycle of chemotherapy for 30 minutes, using the same provider, with the patient resting in a chemotherapy recliner. Standard manual massage techniques were individualized and employed over the head, neck, shoulders, back, hands and/or feet.
Healing touch was delivered following massage therapy. Prior to the first session a handout describing healing touch was given to participants in the active group. Treatment was provided by one healing touch practitioner who was certified in the practice. Sessions were tailored to patients' needs and lasted 30 minutes.
At each chemotherapy visit subjects underwent performance assessment and laboratory testing that included immune parameters such as white blood cell count with differential, T and B-cell count, salivary IgA levels, and NK cell count. Quality of life was assessed prior to chemotherapy cycles 1, 3, and 6, as well as 6 months after chemotherapy was completed, using the FACT-O and Mental Health Inventory. Information on delays in chemotherapy protocol, infection rate, re-hospitalization rate, and antiemetic use was collected prospectively. Demographic and disease stage information were also collected.
A total of 43 women with ovarian, primary peritoneal, or fallopian tube cancer were recruited into the study, with 20 randomized to the control arm. The groups were comparable at baseline on the basis of demographics and disease state. One patient withdrew consent prior to receiving any treatment and was removed from analysis.
Multimodality IM was deemed both feasible and acceptable to all the women enrolled in the active arm. Each received the full slate of interventions in their chemotherapy chairs. The IM interventions did not interfere with the delivery of chemotherapy. Average FACT-O and MHI survey scores revealed no statistically significant differences between the groups at any time point. Save for some immune function measurements, no differences were found between the groups for any of the other parameters being followed. WBC counts were no different between groups, but compared to controls, participants receiving multimodal IM had consistently higher CD4, CD8, and NK cell counts at each cycle of chemotherapy. The differences were not statistically significant.
The authors concluded that offering combined IM therapies to women receiving chemotherapy for gynecologic malignancies is feasible and well-tolerated, but may not offer clinically important effects on quality of life as presupposed.
Commentary
Women being treated for ovarian cancer report high levels of depression and anxiety. Many turn to CAM therapies for relief, and some trials have reported benefits on measures of emotional and physical well-being, and even on measures of immune modulators in some trials. Some consider the addition of CAM therapies to the conventional medical armamentarium equivalent to integrative care. It is not.
There are many ways that integrative medicine can be defined, but perhaps the most accepted definition comes out of the Arizona Center for Integrative Medicine at the University of Arizona: "Healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative." There are other important tenets, including that good medicine is based in good science, is inquiry-driven, and is open to new paradigms. But another central theme is individualization of care, and that's a major concern with this paper.
The authors of this well-done trial sought primarily to assess the feasibility of providing a preset combination of CAM therapies (clinical hypnosis, massage therapy, and healing touch/energy work) to patients in and around the time of administration of chemotherapy. They succeeded in showing that such an approach could be offered without interfering with conventional care and in a manner that was acceptable to participants. Keeping in mind the small sample size, the authors' assertion that the study was inadequately powered to determine the clinical impact of their multimodality CAM approach, and the lack of blinding, the conclusion that some will nonetheless glom onto is that little or no clinical benefit is associated with an "integrative oncology" approach. Consider, however, that three separate forms of care were offered at each chemotherapy session, and none (except for the opportunity to listen to hypnosis tapes) in between sessions. Consider that in a truly integrative approach the needs of the individual would determine whether or not hypnosis, massage therapy, and/or healing touch would be recommended at all. Consider that in reality many, if not most, patients receive the majority of CAM treatments before or after the date of chemotherapy administration, or that receiving three separate forms of care together with chemotherapy might be stressful and time-consuming for some. Lastly, consider that diet and lifestyle measures, the centerpiece of integrative care, were not the centerpiece of care.
A combined offering of preset CAM therapies to people on the day they are to receive chemotherapy is unique and potentially beneficial, but in and of itself does not set the standard for integrative oncology, where a given approach is decided upon and utilized based on the individual nature of the patient and her needs.
The study was very well done and shows that clinical hypnosis, massage, and energy work can be offered to patients, combined or separately, in the infusion center without disrupting care. The findings cannot reasonably be used to determine the clinical utility of this combination of therapies due to the shortcomings readily stated by the researchers, nor should it be used to judge integrative oncology as a whole. Grafting a set of CAM therapies onto the conventional medical treatment of cancer is not synonymous with integrative medicine.
Results from this small pilot trial suggest that clinical hypnosis, massage, and energy work can all be offered to people receiving chemotherapy without interfering with conventional medical care. The findings also suggest little clinical benefit, but there are considerable study limitations, and the findings speak more to feasibility than to therapeutic utility.Subscribe Now for Access
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