IV ALA & ALA/LDN/HCA Treatment

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Evidence

Evidence exists to support the co-administration of LDN and ALA, with HCA in some cases²

A 2014 Journal Article “Metabolic Treatment of Cancer: Intermediate Results of a Prospective Case Series” discussed the co-administration of ALA, LDN and another similar substance HCA – which is a common weight loss product – in patients that had failed conventional therapies.

Lung Cancer patient. She was told by her referring oncologist in 12/2012, that she had less than three months to live. Because of extensive lung metastases, she was receiving oxygen.

Mid-January 2013 began treatment with IV ALA at 600 mg/day, HCA at 500 mg three times a day and naltrexone at 4.5 mg/day. PET scan May 2013 showed stabilization of the disease.

Colon cancer patient with multiple liver metastases. She failed three lines of chemotherapy. She started ALA, LDN, HCA  03/2013. The first CT scan on 05/2013 demonstrated tumor progression but the next one, one month later showed stable disease.

Ovarian cancer patient was diagnosed in 09/2008. She was first treated with paclitaxel, carboplatin and bevacizumab, then bevacizumab, caelix and cyclophosphamide, followed by immunotherapy. In 03/2013, she started ALA, LDN, HCA treatment with paclitaxel-based chemotherapy again. The ovarian tumor has grown slowly since. She died in 12/13 of tumor progression.

Esophageal cancer patient 10/2011 with multiple metastases to the liver and lymph nodes. FOLFOX was stopped in 04/2012 due to a complete response. Because of local and metastatic relapse, ALA, LDN, HCA was started in 03/2013 but failed to prevent massive tumor growth. In 05/2013, treatment was switched to FOLFIRI chemotherapy. It resulted in massive tumor shrinkage. The last CT scan of late 11/2013 demonstrated partial regression of the liver metastases.

Uterine cancer diagnosed in 2007. She was treated with surgery, postoperative radiation therapy and chemotherapy. In 01/2013, the tumor relapsed with 14 different brain metastases. She was treated with palliative radiation therapy. In early March 2013, she started ALA, LDN, HCA. The last (MRI) dated 06/2013 showed almost complete disappearance of brain lesions. As of late 2013, she is living a normal life.

Gallbladder cancer patient - had a partial liver resection in 02/2012. Despite FOLFOX, she developed multiple lung metastases in 6/12. Treatment with Sutent cancer medication was ineffective. She started ALA, HCA, LDN with Sutent.  05/2013 CT scan showed no progression of the disease. The last PET scan of late August 2013 showed stabilization of the lung metastases but the appearance of small abdominal lymph node metastases. In 11/2013 there was a limited tumor progression and xeloda was added.

Parotid (salivary gland) tumor patient. The tumor relapsed in 11/2011. Multiple lung metastases were diagnosed in 10/2012. Chemotherapy with carboplatin and paclitaxel was ineffective. The addition of bevacizumab had no positive effect. In 06/2013, she started ALA, LDN, HCA. In 09/2013, a CT scan demonstrated stabilization of disease.

Prostate Cancer: A 73-year-old patient had been diagnosed in 2005 with a high-grade prostate cancer. Despite surgery and postoperative radiation therapy, PSA levels remained elevated. Treatment with decapeptyl (hormonal therapy) was effective up to 01/2013. Because of marked increase in PSA, casodex (another hormonal therapy) was added. The patient was informed of the dismalprognosis of the disease. Alpha Lipoic Acid and HCA were added with a rapid decrease in PSA.

Follow up data

In 2016, a follow up study was published by the above authors. They mention that 32 months after inclusion, 5/11 of the above patients (45%) were still alive.

The cases of a further 12 patients with advanced brain tumors was reported. These patients were all treated with conventional treatment and a combination of sodium R lipoate (800 mg bid), hydroxycitrate at 500 mg tid and low-dose naltrexone at 5 mg at bedtime.

Eight patients had primary brain tumour (including five glioblastomas) and four patients had multiple brain metastases. These glioblastoma patients had concomitant radiation therapy and chemotherapy
(temozolamide).

At the time of writing, five out of six patients with glioblastoma were alive and stable after two years, with the longest follow-up being 7 years. The four patients with brain metastatic involvement experienced long-term survival, with two of the four patients with multiple brain metastases well after three years.⁹  

In another study, four lung patients (primary adenocarcinoma) were treated with a combination of the small molecule EGFR inhibitor, Gefitinib, and metabolic treatment (α-lipoic acid/hydroxycitrate). They all responded to treatment and are stable one year after the start of therapy.⁸

Leukemia¹:

A trial involving 89 leukemia patients conducted in Iran demonstrated improved quality of life with LDN, however, exact details of this study were not obtained. However, it does imply that LDN has potential in this population.

Pancreatic Cancer: Successful treatment with LDN and ALA

There is evidence to suggest synergy of Alpha Lipoic Acid and Gemcitabine and HCA³. An 80 year old pancreatic cancer patient with liver metastases had a predicted survival between 3 and 6 months. As of March 18, 2010, the patient was still alive, meaning that she had survived for 8 months following the treatment. The patient was also on Celebrex and Melatonin which also can have modest anti-cancer activity. The authors note that a worsening in March 2010 was potentially due to withdrawal of the Lipoic acid and hydroxycitrate and Celebrex by the patient

Some of the most compelling evidence for alternative cancer treatments is from a series of case reports using intravenous ALA and LDN orally similar to the above case reports, however without the use of HCA.

A 2009 Article from Berkson discusses three cases that responded impressively to this protocol.

“Revisiting the ALA/N (alpha-lipoic acid/low-dose naltrexone) protocol for people with metastatic and nonmetastatic pancreatic cancer: a report of 3 new cases”

Case A: Alive and well 78 months after initial presentation (a patient from an earlier report)

Patient 1: is alive and well 39 months after presenting with metastases to the liver.

Patient 2: presented with liver metastases and after 5 months of therapy, PET scan demonstrated no evidence of disease.

Patient 3: Presented with metastases to the liver and one other region. After 4 months of the ALA/N the

A similar response was described in a 2006 journal article by the same group.

Berkson 2017: 

In this case report, a 64-year-old male patient diagnosed with metastatic renal cell carcinoma that despite left nephrectomy and the standard oncological protocols (bevacizumab, sunitinib and sorafenib) the patient’s condition continued to worsen, the patient developed a solitary left lung metastasis that continued to grow.

He was informed that given his diagnosis and poor response to conventional therapy, any further treatment would, at best, be palliative. When he started his integrative program he was was in very poor health, weak, and cachectic.

The key therapeutic agents initially prescribed by were intravenous (IV) vitamin C 25 to 50 g every morning and IV R+ α-lipoic acid (ALA) 300 to 600 mg every afternoon.

The oral protocol included low-dose naltrexone (LDN) 4.5 mg at bedtime, and "the oral Triple Antioxidant Therapy protocol" with R+ ALA 300 mg twice daily, selenomethionine 200 µg twice daily, and silymarin 900 mg twice a day along with 3 B complex capsules a day.

Oral hydroxycitrate (HCA) 500 mg 3 times daily was later added to the protocol (September 2013). 

After only a few treatments of IV α-lipoic acid and IV vitamin C, his symptoms began to improve, and the patient regained his baseline weight.

He continued the IV ALA infusions twice a week and IV vitamin C twice a week. The patient continued to visit the author's clinic every 3 months for a week or two of intensive daily IV vitamin C and IV ALA therapy.

In January 2011, a repeat PET/CT scan was performed. Again, the mass in the left lung was demonstrated, with no apparent change in size. However, in June 2011, another PET/CT scan showed that the upper lung mass was much smaller in size.

His energy and outlook improved, and he returned to work. The patient had stable disease with disappearance of the signs and symptoms of stage IV RCC, a full 9 years following diagnosis. As of November 2017 the patient feels well and is working at his full-time job.

Case Reports for LDN

Lymphoma⁵:

2007 Case report, aptly named Reversal of signs and symptoms of a B-cell lymphoma in a patient using only low-dose naltrexone.

A follicular lymphoma (the most common type of non-hodgkin lymphoma) was diagnosed and the patient declined conventional treatment. Seventeen months after the initial diagnosis the patient was started on LDN. The patient also completed nine alpha lipoic acid infusions. By the sixth month point the nodes had significantly resolved with further confirmation by CT/PET scans.

Our Naturopaths have followed a long term case of follicular lymphoma at our Edmonton office that did exceedingly well with intravenous Alpha Lipoic Acid and a Ketogenic diet. Hyperbaric treatment was not offered at our office at this time. 

Medicor Case Reports¹:

A presentation in February 2016 by Akbar Khan MD discussed specific case reports where the results were clearly attributable to LDN: 

Lymphoma

Small intestine cancer

Bladder cancer X 2

Colon Cancer

Tongue Cancer

Dr. Bihari case reports⁶:

In the clinic of Dr Bernard Bihari, in 2002 fourteen cases were chosen by an oncologist from the National Cancer Institute with a clear cut response to LDN:

Lung Cancer x 2

Melanoma

Esophageal Cancer

Kidney Cancer

Lymphoma x 3 Cases (2 Non-Hodgkin, and 1 Hodgkin)

Prostate

Pancreatic

Carcinoid

Multiple Myeloma

Breast

Ovarian Cancer 

Our Naturopathic Doctors consider referral for LDN especially in all these listed cancers. Referral is to local prescribing professionals in Edmonton. 

hyperbaric oxygen

Our clinic offers Edmonton state of the art Hyperbaric chambers. There is reported synergy between Hyperbaric oxygen and other metabolic supports in the context of Alternative Cancer Care.

In part based on "Metabolic Updated Protocol – 2020 Anderson¹¹" an article published by Paul Anderson ND discussing "Metabolic Therapies in Advanced “Salvage” Cancer Cases."

Dr. Anderson discusses the synergy between *DCA, Retinoids, PolyMVA, Alpha Lipoic Acid and Hyperbaric Oxygen Therapy (*note our office does not offer DCA).

PolyMVA is palladium bonded to alpha-lipoic acid (they are irreversibly bound together resulting in a molecule that is both fat and water soluble) with Vitamins B1, B2 and B12, formyl-methionine, N-acetyl cysteine,and trace amounts of molybdenum, rhodium, and ruthenium. It's thought to be a "supercharged" Alpha Lipoic Acid. We've used PolyMVA in our Edmonton office orally, intramuscularly as well as intravenously. It's costly which has primarily limited our use of it in place of Alpha Lipoic Acid and the published data for ALA for cancer care is far more established.

Metabolically speaking, PolyMVA is thought to support the electron transport chain specifically (accept and donate charge) resulting in improve mitochondrial energetics. 

Anderson agrees with other Hyperbaric literature we've referenced that "HBOT alone offers limited curative effect and is typically not used as monotherapy," that is, he views it as a synergist with other metabolic therapies. 

Benefits were seen in this combined metabolic approach in Lymphoma, Leukemia, Multiple Myeloma and GBM and CLL possibly as well from just oral metabolic therapies and "later additions such as HBOT, Exogenous Ketones etc. have only IMPROVED outcomes." Interestingly, "The ONE main discriminator of success above all others was ability to make the diet changes." Our Naturopaths are strong proponents of Ketogenic diets alongside metabolic therapies as well.

Anderson notes "while nothing certainly works universally in advanced cancer a combined metabolic protocol should be considered as a potential therapy in all cases."

Anderson's Combined Metabolic Oncology Therapy – Protocol:

1. Dietary Intervention

2. Use of supplemental retinol (Vitamin A). 

3. Use of intravenous Poly-MVA and DCA

4. Addition of hyperbaric oxygen therapy (HBOT)

Use of concurrent Hyperbaric chamber:

• Begin with a 1.3 to 1.5 ATA trial, bottom time 60 minutes with O2 by mask.

Dive may be increased to 1.5 ATA X 60 minutes.

• With the full protocol above TWO HBOT dives per week are optimal.

The reality of Anderson's Combined Metabolic Oncology Therapy, is that there is strong mechanistic synergy between metabolic treatments like ALA (or PolyMVA) and other metabolic treatments like Hyperbaric Oxygen and Ketogenic diets and substances like DCA.

Hyperbaric Oxygen is a strong driver of oxidative phosphorylation and as noted above, Alpha Lipoic Acid also works to this end as it is a cofactor for the pyruvate dehydrogenase which converts pyruvate into acetyl CoA, which then drives the Krebs cycle.

Other synergistic therapies to Hyperbaric Oxygen and Alpha Lipoic Acid include: B1, Acetyl-L-Carnitine, Niacinamide and Metformin, and possibly CoQ10, PQQ, Solomon's Seal and Quercetin (The Mitochondrial Rescue protocol popularized by Dr. Neil Mckinney).

As discussed in the Hyperbaric Oxygen Section, metabolically supported chemotherapy (MSCT) combines different chemotherapy regimens alongside ketogenic diets and hyperbaric oxygen therapy. It would be expected that other metabolic treatments such as IV ALA would further improve efficacy of MSCT. This is also expected based on the in vivo data presented by Poff and D’Agostino (2013) where Ketogenic diets were strongly synergistic with Hyperbaric Oxygen Treatment and Ketogenic diets. 

Clinical Experience

LDN is extremely well tolerated with some patients reporting vivid dreams which is usually dealt with titrating the dose down. It is also extremely cost effective. There is an incompatibility with opiate pain medications such as morphine and codeine most commonly seen as Dilaudid and Tylenol 2,3 and 4 however combining LDN and opiates can sometimes be achieved if the medications are immediate release preparations and LDN is spaced away.

NSAIDs, Muscle relaxants and topical analgesics are encouraged as well. LDN has a wide range of use and has been studied in Autoimmune Disorders (Crohn’s & MS), Fibromyalgia and Autism.

Metabolic cancer protocols, as with any cancer protocol, do not always work in every case. However, in our 10+ years of Alternative Cancer care we've seen responses more often and more robust with metabolic therapies than with other approaches (oxidative, anti-oxidant). Therefore, our Naturopathic doctors always consider integration of metabolic cancer therapies as part of our protocols for our Edmonton patients. 

Based on the available evidence, Alpha Lipoic Acid when given intravenously appears to have a strong effect in particular cases. Based off the experience of Anderson, it appears that IV ALA (and PolyMVA) do in fact synergize with Ketogenic diets and Hyperbaric Oxygen.