This randomised controlled trial has now completed. The results were announced as a full oral presentation at the world's largest and most prestigious cancer conference ASCO in 2013. The full paper was published in a Nature Journal in 2014. In 2016, a further trial was conducted and published which confirmed the very low progression of PSA in men taking Pomi-T on surveillance but also confirmed that this correlated with underlying control of disease seen on MRI (read second paper).

The supplement used in this trial had the highest practicable quality assurance, including specific test for authenticity, purify and lack of heavy metal or bacterial contamination of the ingredients. In addition, an independent academic body performed mass spectrometry to ensure no unexpected additives were present. The original manufacturers agreed with the clinical trials committee to continue this high quality assurance programme but unfortunately unregulated copies have since appeared on some UK and international websites. If you are interested in taking Pomi-T we recommend you refer to the original regulated website and avoid discount stores which may not adhere to the same quality assurance.- link to Pomi-T website.

Background to the study 

An increasing numbers of published studies have linked polyphenols, the natural plant based phytochemicals found in healthy foods, with a lower risk of chronic illnesses such as dementia, arthritis, skin aging, macular degeneration and more recently cancer [Rezai-Zadeh], [Maclarty]. Women with early breast cancer taking higher than the recommended “5 a day” amount of fruits and vegetable have been found to lower their risk of recurrence risk by one third especially if combined with physically activity [Pierce 2009]. Breast cancer recurrence has been demonstrated to be lower amoung women regularly drinking green tea [Ogunleye 2010] or eating foods rich in dietary lignans [Buck 2011], isoflavones and flavanones [Boyapati 2005]. A full scientific review of the evidence for polyphenols and cancer has been conducted by the trials team and can be downloaded free.

Although the benefits of boosting the diet with polyphenol rich whole food supplements for individuals with cancer have been investigated in small phase II studies, they have rarely been evaluated within an adequately powered Randomised Controlled Trials. For this reason, the UK’s government’s clinical trials design committee decided to set up a national trial to investigate whether there are any anticancer benefits. These committee green tea, broccoli, turmeric and pomegranate of chose these foods as they originate from separate categories (spice, herb, fruit, vegetable), hypothesising that their diverse polyphenol profile would have synergistic action whilst avoid accumulation of one particular phytochemical. Each ingredient has also demonstrated anti-oxidant activity, protecting cells from carcinogenic exposure, as well as direct anti-neoplastic activity within previous laboratory or phase II trials:

• Green Tea, rich in epigallocatechin gallate, blocks ornithine decarboxylase resulting in reduced proliferation, angiogenesis and de-differentiation in cancer cell lines. A meta-analysis of 5000 women showed that regular consumption had reduced breast cancer recurrence. Phase 2 studies have demonstrated reduced PSA in prostate cancer [Mclarty, Ogunleye Porrini, Liao].

• Pomegranate, rich in ellagic acid, which in cancer cell lines reduced proliferation, apoptosis and adhesion. In 3 phase II studies it prolonged PSAdt and reduced oxidative stress [Retitig, Lansky, Malik, Barber, Rocha, Wang, Pantuck, Carducci, Paller]. 

• Turmeric, rich in capsaicin reduced growth, invasion, migration, and TK activation of EGFR. In cancer stem cells it prevented progression to prostate, bowel and breast cancer but had no affect on normal stem cells. In humans has demonstrated Cox-I anti- inflammation effects [Kakarla, Shah, Zhang, Dorai] 

• Broccoli, rich in iothiocyanate, in cell lines slows growth and promotes apoptosis. In humans after regular consumption it alters genetic signature, down regulates promoting genes, up regulate cancer suppressor genes [Gasper, Joseph, Heinen].

Methodology

Two hundred and three men, aged 53-89 yrs (average 74 yrs), with prostate cancer (95% Gleason 6/7, 5% >7), 59% managed with primary active surveillance or 41% with watchful waiting (WW) with a progressive PSA relapse following previous radical interventions were randomised to receive a Pomi-T or an identical placebo for 6 months. The randomised process produced no statistical difference in baseline characteristics except the placebo group were slightly older which, if anything would be more advantageous to the placebo group. The power calculation and independent statistical analysis took place at Cranfield University and men were recruited from across the UK. Enthusiasm to enter the study was overwhelming. The trials team completed the quota 10 months ahead of schedule (see graph).

Quality assurance: This non commercial academic trial received peer reviewed sponsorship from Prostate Action, was designed by NCRI Complementary Therapies Research Committee, adopted by the UK’s NCRN and independently audited to ensure it adherence to European Good Clinical Practice Guidelines. The manufacturers performed in house analysis to ensure authenticity and purity and a further independent mass spectrometry was performed to confirm purity. Statistical evaluation was independent to the trials unit. 

Results: Two men from each group men withdraw before the first 3 month evaluation.  of the remaining 199 men, the median rise in PSA in the Pomi-T was 14.7% (95% CI 3.4-36.7%) v 78.5% in the PG (95% CI 48.1-115.5%). This difference of 63.8% was significant (ANCOVA p=0.0008). 18.6% more men stayed off interventions at the end of the trial in the Pomi-T group. There was no significant difference between any of the pre-determined subgroups.

Secondary end points: There was no effect on average serum sex hormone analysis: Testosterone 13.4 nmol/l (nr 9-29) FSH 9.2 iu/l (nr 2-12), LH 7.4 iu/l (nr 2-9) There was no effect on cholesterol, INR or BP amoung men taking warfarin or ramipril. MRI scans, taken routinely as part of their AS protocol, were retrospectively evaluated. 35% had no visual disease, 15% had progressive disease with significant rises in PSA (removed from trial) 50% had visual disease with no progression, no man remaining on Pomi-T had MRI defined progression. There was a 14% difference in urinary symptoms (mainly urgency) and a 6% difference in joint pains although these two endpoint were not predetermined in the statistical plan so need further varification.

Conclusions: In this cohort of men with prostate cancer managed with AS or WW this study demonstrated 6 months of Pomi-T  demonstrated highly statistically significant short term favourable effect on the percentage rise in PSA compared to placebo. It was well tolerated without any significant adverse effects or concomitant drug interactions and resulted in significantly more men remaining on AS or WW avoiding the toxicities and expense of medical interventions. No change in testosterone levels occurred in men taking Pomi-T and disease seen on MRI correlated with PSA dynamics.

The PSA - MRI correlation study 

A second evaluation has taken place involving men who have continued to take pomi-t post trial. It specifically addressed the issue of of whether PSA correlated with underlying changes in Cancer size seen on MRI. It involved men followed for up to 2 years on active surveillance. 

The results, as shown in the adjacent picture, should a 100% correlation between PSA and underlying disease indicating that the PSA effect on the main Pomi-t trial was unlikely to be just a chemical effect but related to actual prostate cancer itself - read full paper

The trials team has now designed a RCT  evaluating  a polyphenol rich nail balm with the aim of reducing chemotherapy induced nail damage  this trial is underway - read more.

The team has also performed two evidence reviews summarising the evidence for polyphenols and exercise. A further evidence review examining the Biology of exercise has been write with Coventry University and Stacey Kenfield from the University f South California and been published in the British Journal of Sports medicine and is available to read here.

The trials unit are moving on to evaluate the evidence for a polyphenol rich supplement to improve arthritis and  exercise levels. In the mean time they have successfully designed and conducted  a double blind randomised trial of a polyphenol rich nail balm to stop distressing chemotherapy associated nail damage. This trial known as the polybalm study has been published in ASCO 2017.... read more

The Tokyo Women's study

The effect of a boosting phytochemical rich foods for women’s cancer survivors on arthralgia, mood and hot flushes. 

Yanagisawa Y et al (2021). J Nurs Women’s Health 5: 168. DOI: 10.29011/2577-1450.100068

Background and rationale: Late toxicities such as arthritis, low mood, nail changes and hot flushes are common after breast, other women’s cancers and after menopause in general.  As well as causing discomfort impacting quality of life, persistent arthralgia can  compromise the effectiveness of adjuvant therapies by reducing compliance to hormone treatment. Discontinuation rates of hormone therapies such as tamoxifen and aromatase inhibitors have been recognised  in up to 30% of women suffering from arthralgia and stiffness. Poor adherence to AI therapy has also been associated with worse disease-free and overall survival from breast cancer. In addition, arthritis can significantly  impact patients ability to exercise, which  can lead to an exacerbation of further  symptoms and complications  associated with  cancer. In particular, regular exercise can mitigate  the risks of weight gain, hot flushes, fatigue, peripheral neuropathy, erectile function, arthritis itself and osteoporosis, as well as improve  mood and sleep patterns. Restricted mobility may have even more sinister consequences for patients, as cohort studies have consistently linked a reduced relapse rate and improved survival benefit amongst those able to be physically active after several different types of cancer, including breast cancer.....

Epidemiology studies have linked higher intake of polyphenol-rich foods with better gut health mood and less arthritis. Lab studies show these foods reduce intra-articular inflammation and oxidative stress,  allowing greater mobility although, up until now, clinically relevant, intervention studies in humans have been lacking. A whole food nutritional supplement can be a convenient way to boost intake of polyphenol-rich foods and ensure sustained  intake throughout the day. For this study the OTC supplement Pomi-T was selected given that  it has demonstrated a high safety profile in a randomised trial in which participants also reported improvements in joint discomfort. Pomi-T also contains no phytoestrogenic polyphenols, which may potentially would have been a concern post breast cancer...

How was the study conducted:
This was an open label evaluation of a polyphenol-rich whole food supplement (Pomi-T) supplied to volunteer members of a Japanese Women’s Cancer Support Group, Tokyo. Joint discomfort, mobility, mood and hot flushes were recorded at baseline and after 2 months Pomi-T using validated peer reviewed questionnaires. 38 of 44 (87%) completed pre and post forms (average age 48, range 26-62 years).

Conclusion: This open labelled study demonstrated that symptomatic women with breast and other had a statistically significant reduction in arthralgia, hot flushes and improved mood after consuming two capsules of Pomi-T per day.  This evaluation did not formally measure hay fever symptoms, and the comments from the participants were spontaneous. This was not  completely unexpected,  as polyphenols have previously been investigated for their anti-allergic effect in models and in human clinical trials [97, 98]. This evaluation took place in late spring in Japan, just before the “Cherry Blossom” season which is  associated with a higher pollen count. It would be interesting to repeat this evaluation focusing specifically on the effect of Pomi-T in individuals who suffer from hay fever  over a  similar time period using designated formal measures of allergy symptom severity.

Read more on the Pomi-T website

Administration: Lifestyle after cancer: Cancer treatments: Symptoms:  Disclaimer About us Site map Contact us Links to support groups Trials & research Other health issues Submit a poem Making a living will Order a nutritional test Traveling advice Measure patient satisfaction Diet Exercise Carcinogens Quit smoking Weight Gain Sun exposure Alcohol Sleep hygiene Bone Health Micro-nutrients The Pomi-T trial Healthy bacteria Chemotherapy Radiotherapy Hormone therapies Targeted therapies High frequency ultrasound Complementary therapies Lifestyle strategies Common tests Having a picc line Support drugs Preventing a sore mouth Preventing nail damage Hot flushes Joint pains Hair loss Nail damage Chemo-brain Fatigue Dupuytren's Sore Lips Menopause Hot flushes Weight gain Breast tenderness Receive our monthly lifestyle research updates Email:   Newsletter Archives This book, with a foreword from Paula Radcliffe, contains research based guidance showing how diet, exercise and other lifestyle changes can; help avoid cancer, cope with treatments side effects; slow progression and prevent relapse ..more Micro-nutrient testing empowers you to make dietary choices specific to your personal make up. This test analyses over 50 of the essential blood micro-nutrients and recommends specific dietary and supplement advice to ensure you have the best possible nutritional status to help fight cancer and aid recovery from treatments ..more . Vitamins & Cancer:   Vitamin A Vitamin B Vitamin C Vitamin D Vitamin E Vitamin K & K2 . Essential minerals & cancer:   Zinc Selenium Magnesium Iron Chromium Copper   . Specific foods & cancer:   Green Tea Broccoli Pomegranate Turmeric Organic food? Process sugar . Fats & cancer:   Unhealthy fats Healthy fats Omega 3 Omega 6 Omega Healthy fats in meals . Other issues & cancer:   Gut health Chronic inflammation High blood sugar High cholestreol Healthy recipes Cycling and prostate ca