We are studying the changes of the microbiome of people being treated for Pelvic Area Cancer to see if they have the same amount of side effects from either one of two different external radiation treatments: Intensity Modulated Proton Therapy (IMPT) or Intensity Modulated Radiation Therapy (IMRT).

 Both IMPT and IMRT have been used in the treatment of cancerous tumors and are thought to be equally effective at curing Pelvic Area Cancers, with both causing significantly different radiation induced side effects of the bowel and urinary tract as well as erectile dysfunction and vaginal stenosis.  

Although IMRT and IMPT are types of “external beam” radiotherapies that shape the radiation to the cancerous tumor, the properties of each are very different and result in varying levels of radiation exposure:

IMRT utilizes a number of x-ray beams that contain no mass or electrical charge and deposit most of the initial dose of radiation (entry dose) close to the patient’s skin and deeper tissues, organs and bones along its paths before reaching the tumor.

On the other hand, IMPT utilizes pencil-beam proton radiation therapy radiation doses that can be controlled to deposit most of the energy inside the tumor. Protons are subatomic particles occurring in all atomic nuclei with a positive electric charge that can be manipulated and controlled to stop delivering radiation directly at a tumor and traveling no further than the exterior tumor wall. In other words, protons can be directed to enter the body and deposit only a small dose along the way to the target and virtually none beyond it.

Unlike IMRT and pre-2018 standard proton therapy (PBT), IMPT conforms to the unique shape and size of the tumor with near precision (within 2 millimeters) sparing surrounding healthy tissues, organs, and bones, which is particularly beneficial to those who are vulnerable to radiation, would like to reduce the risks of infertility, or have received prior radiation either to or immediately adjacent to the area that needs to be treated.

Although there is one study in progress (Efstathiou and Bekelman, 2012-2026) that compares the side effects of IMRT and PBT for prostate cancer, there has never been a study that includes both men and women in the comparison of the acute radiation syndrome of IMRT and IMPT to see which one has fewer and/or lesser degree of side effects with respect microbiome composition (see 2021 impact and review) on gastrointestinal symptoms (i.e. chronic diarrhea and/or weight loss syndrome cachexia) as well as neuropsychological and peripheral neuropathological symptoms (i.e. memory loss, poor brain function, stroke-like symptoms and muscle weakness-dysfunction) that may affect quality of life of chemo-radiated patients and be lifelong.  A discussion on the impact of post-radiation fertility of the reproductive organs of each participants will be included.

This study design is four-armed to include pre/post-cancer treatment, with comparisons drawn from an integrative care versus standard care approach. Two arms will compare people, both men and women, undergoing IMRT to IMPT treatment with standard oncological care and two additional arms comparing people undergoing IMRT and IMPT treatment with both standard oncological care and integrative care, which will implement a targeted Integrative Health Program (IHP) in alignment with NIH NCCIH recommendations for cancer treatment that will include a pre-treatment integrated plan that will continue through treatment until the conclusion of the study. All four arms of the study will have a special focus on the microbiome and quality of life of each person undergoing treatment that will involve laboratory testing and evaluations.

The President and First Lady launched the White House Initiative on Women’s Health Research in November of 2023 with a clear goal:  to fundamentally change how our country approaches and funds research on women’s health.

TOO MANY medical studies have focused on men and left women out.

TOO MANY of the medicine dosages, treatments, medical school text books, are based on men and their bodies – and that information doesn’t always apply to women.

That means there are BIG GAPS in medical research on:

Diseases and conditions that only affect women (e.g., menopause, endometriosis)

Diseases and conditions that disproportionately affect women (e.g., Alzheimer’s)

Diseases and conditions that affect women and men differently (e.g., heart disease)

These gaps in research mean we know far too little about women’s health – and those gaps are bigger for women of color and women with disabilities.